T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies

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ClinicalTrials.gov Identifier: NCT02659943

Recruitment Status : Completed

First Posted : January 21, 2016

Results First Posted : May 4, 2021

Last Update Posted : April 19, 2023

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Sponsor:

Information provided by (Responsible Party):

James Kochenderfer, M.D., National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Lymphoma, B-Cell Lymphoma, Non-hodgkins
Interventions	Biological: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Drug: Cyclophosphamide Drug: Fludarabine
Enrollment	27

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only	Participants Enrolled But Not Treated
Arm/Group Description	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...	Participants who were enrolled but ...
Arm/Group Description	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only	Participants who were enrolled but not treated.
Period Title: Overall Study
Started	3	2	1	4	2	9	6
Completed	2	0	0	1	0	4	0
Not Completed	1	2	1	3	2	5	6
Reason Not Completed
Switched to alternative treatment	1	1	0	2	1	0	1
Disease progression on study	0	1	1	1	1	4	0
Patient's condition per principal investigator	0	0	0	0	0	1	0
Ineligible	0	0	0	0	0	0	1
No longer meets eligibility	0	0	0	0	0	0	1
No treatment, per protocol	0	0	0	0	0	0	3

Baseline Characteristics

Arm/Group Title		LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only	Participants Enrolled But Not Treated	Total
Arm/Group Description		LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...	Participants who were enrolled but ...	Total of all reporting groups
Arm/Group Description		LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only	Participants who were enrolled but not treated.	Total of all reporting groups
Overall Number of Baseline Participants		3	2	1	4	2	9	6	27
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Baseline data was collected and reported here for the participants enrolled but not treated.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	2 66.7%	2 100.0%	0 0.0%	3 75.0%	1 50.0%	6 66.7%	4 66.7%	18 66.7%
	>=65 years	1 33.3%	0 0.0%	1 100.0%	1 25.0%	1 50.0%	3 33.3%	2 33.3%	9 33.3%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
		55.6 (10.14)	50.35 (3.04)	68.6 (0)	57.2 (8.61)	65 (5.09)	57.11 (10.8)	52.98 (16.32)	56.55 (11.05)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
	Female	2 66.7%	1 50.0%	1 100.0%	0 0.0%	0 0.0%	5 55.6%	2 33.3%	11 40.7%
	Male	1 33.3%	1 50.0%	0 0.0%	4 100.0%	2 100.0%	4 44.4%	4 66.7%	16 59.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	1 3.7%
	Not Hispanic or Latino	3 100.0%	2 100.0%	1 100.0%	4 100.0%	2 100.0%	7 77.8%	6 100.0%	25 92.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	1 3.7%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	1 50.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	3 100.0%	1 50.0%	1 100.0%	4 100.0%	2 100.0%	8 88.9%	6 100.0%	25 92.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	1 3.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
United States		3	2	1	4	2	9	6	27
Prior Lines of Therapy Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
1 Line of therapy		0 0.0%	0 0.0%	0 0.0%	1 25.0%	0 0.0%	0 0.0%	1 16.7%	2 7.4%
2 Lines of therapy		0 0.0%	1 50.0%	0 0.0%	1 25.0%	1 50.0%	2 22.2%	1 16.7%	6 22.2%
3 Lines of therapy		1 33.3%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	1 11.1%	1 16.7%	4 14.8%
4 Lines of therapy		1 33.3%	0 0.0%	1 100.0%	1 25.0%	0 0.0%	4 44.4%	0 0.0%	7 25.9%
5 Lines of therapy		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	2 33.3%	3 11.1%
6 Lines of therapy		0 0.0%	1 50.0%	0 0.0%	1 25.0%	0 0.0%	1 11.1%	0 0.0%	3 11.1%
9 Lines of therapy		1 33.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 16.7%	2 7.4%
Lymphoma Type Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	3 participants	2 participants	1 participants	4 participants	2 participants	9 participants	6 participants	27 participants
DLBCL		1 33.3%	0 0.0%	0 0.0%	1 25.0%	1 50.0%	4 44.4%	3 50.0%	10 37.0%
DLBCL transformed from follicular lymphoma		0 0.0%	1 50.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%	0 0.0%	2 7.4%
DLBCL, double-hit		1 33.3%	1 50.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	3 11.1%
DLBCL, triple-hit		0 0.0%	0 0.0%	0 0.0%	1 25.0%	0 0.0%	1 11.1%	0 0.0%	2 7.4%
Mantle-cell lymphoma		0 0.0%	0 0.0%	0 0.0%	1 25.0%	0 0.0%	1 11.1%	1 16.7%	3 11.1%
Follicular lymphoma		1 33.3%	0 0.0%	1 100.0%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	3 11.1%
Burkitt lymphoma		0 0.0%	0 0.0%	0 0.0%	1 25.0%	0 0.0%	0 0.0%	1 16.7%	2 7.4%
CLL/DLBCL		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	1 3.7%
ALL		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 16.7%	1 3.7%

Outcome Measures

1.Primary Outcome


Title	Percentage of Enrolled Participants Who Actually Get Treated
Description	Percentage of participants enrolled who received treatment with Chimer...
Description	Percentage of participants enrolled who received treatment with Chimeric Antigen Receptor (CAR) T cells, Fludarabine and cyclophosphamide.
Time Frame	4-5 weeks after the first dose

Outcome Measure Data

Analysis Population Description

Data is combined for this outcome measure because it is not possible to draw firm conclusions from the small number of participants in each dose level; the data drawn from the overall participant population through the course of the trial is much more meaningful and conclusive. 26/27 participants were analyzed because one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.


Arm/Group Title	All Participants
Arm/Group Description:	All participants who received Biolo...
Arm/Group Description:	All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Overall Number of Participants Analyzed	26
Measure Type: Number Unit of Measure: percentage of participants
	76.9

2.Secondary Outcome


Title	Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD)
Description	Response was assessed by the Revised Response Criteria for Malignant L...
Description	Response was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Complete Remission is complete disappearance of all detectable clinical evidence of disease. Partial Remission is ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive Disease is ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time Frame	30 days post Chimeric Antigen Receptor (CAR) T-cells up to 5 years

Outcome Measure Data

Analysis Population Description

6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Count of Participants Unit of Measure: Participants
Complete Remission After First Re-Treatment	0 0.0%	0 0.0%	1 100.0%	0 0.0%	0 0.0%	0 0.0%
Complete Remission After Second Re-Treatment	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Partial Remission After Second Re-Treatment	0 0.0%	1 50.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Stable Disease After First Re-Treatment	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Stable Disease After Second Re-Treatment	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Stable Disease After Third Re-Treatment	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Progressive Disease After Second Re-Treatment	0 0.0%	1 50.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

3.Secondary Outcome


Title	Number of Participants With a Duration of Best Response in Months
Description	Best Response defined as the first documentation of response was asses...
Description	Best Response defined as the first documentation of response was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Time Frame	Response duration is the time from first documentation of response, which is one month after cell infusion in all participants, until progression, initiation of off-study treatment or the last documentation on ongoing response, approx. one month -5 years.

Outcome Measure Data

Analysis Population Description

No participants were analyzed in the participants enrolled but not treated Arm/Group, thus the table is not included.


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Count of Participants Unit of Measure: Participants
Stable Disease - 1 Month	0 0.0%	0 0.0%	0 0.0%	2 50.0%	0 0.0%	1 11.1%
Stable Disease - 1 Month (first of two treatments)	0 0.0%	1 50.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Stable Disease - 1 Month After First Re-Treatment	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Stable Disease - 2 Months (first of three treatments)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Stable Disease - 2 Months After Second Re-Treatment	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Partial Remission - 1 Month After First Re-Treatment	0 0.0%	1 50.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Partial Remission - 2 months	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 22.2%
Partial Remission - 3 Months	1 33.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Complete Remission - 4 Months (first of two treatments)	0 0.0%	1 50.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Progressive Disease - After first Re-treatment	0 0.0%	1 50.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Complete Remission - 40 Months (first of two treatments)	0 0.0%	0 0.0%	1 100.0%	0 0.0%	0 0.0%	0 0.0%
Complete Remission - 5 Months After First Re-Treatment	0 0.0%	0 0.0%	1 100.0%	0 0.0%	0 0.0%	0 0.0%
Complete Remission - 6 Months	0 0.0%	0 0.0%	0 0.0%	1 25.0%	0 0.0%	0 0.0%
Complete Remission - 6 Months (first of two treatments)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%
Complete Remission - 29+ Months	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%
Complete Remission - 35+ Months	0 0.0%	0 0.0%	0 0.0%	1 25.0%	0 0.0%	3 33.3%
Complete Remission - 45+ Months	2 66.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Progressive Disease	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%

4.Secondary Outcome


Title	Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events
Description	Adverse Events were assessed by the Common Terminology Criteria for Ad...
Description	Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal.
Time Frame	Date treatment consent signed to date off study, approximately 49 months and 19 days.

Outcome Measure Data

Analysis Population Description


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Number Unit of Measure: Adverse events
< Grade 2	2	2	1	3	2	6
Grade 2	0	0	0	1	0	2
Grade 3	0	0	0	0	0	0
Grade 4	1	0	0	0	0	0
Grade 5	0	0	0	0	0	0

5.Secondary Outcome


Title	Median Peak Chimeric Antigen Receptor (CAR) T Cells Level for Participants Treated
Description	A quantitative polymerase chain reaction (PCR) assay or a flow cytomet...
Description	A quantitative polymerase chain reaction (PCR) assay or a flow cytometry assay will be used to quantitate Chimeric Antigen Receptor (CAR) + T cells. The absolute number of CAR+ peripheral blood mononuclear cells (PBMC) will be estimated by multiplying the percentage of CAR+ PBMC determined by PCR by the absolute number of lymphocytes plus monocytes per microliter of blood.
Time Frame	All post-infusion time-points up to at least 2 months after infusion, and CAR+ T cell analysis will continue until the CAR+ T cell level drops to undetectable levels unless a stable low level of CAR+ T cells is present at more than 3 years after infusion.

Outcome Measure Data

Analysis Population Description


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Median (Full Range) Unit of Measure: CAR+cell/microliter of blood
	42 (31 to 606)	6 (1 to 33)	4 ^[1] (NA to NA)	36 (11 to 1258)	6 (0 to 25)	87 (28 to 2216)

[1]

Not available for second cell infusion.

6.Secondary Outcome


Title	Number of Participants Who Had a Second or Third Infusion of Chimeric Antigen Receptor (CAR)+ T Cells
Description	Number of participants who had a second or third Infusion Chimeric Ant...
Description	Number of participants who had a second or third Infusion Chimeric Antigen Receptor (CAR)+ T cells. Participants were eligible for a subsequent CAR T-cell infusion if the response at one month after CAR T-cell infusion was partial remission (PR) or stable disease (SD). Participants could also receive a subsequent CAR T-cell infusion if the response was complete remission (CR) but the malignancy later relapsed. CR, PR, and SD was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Complete Remission is complete disappearance of all detectable clinical evidence of disease. Partial Remission is ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time Frame	Participants could receive subsequent cell infusions any time 1 month after CAR T-cell infusion until 5 years after cell infusion.

Outcome Measure Data

Analysis Population Description


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Count of Participants Unit of Measure: Participants
Second infusion	0 0.0%	2 100.0%	1 100.0%	0 0.0%	1 50.0%	0 0.0%
Third infusion	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	0 0.0%

7.Secondary Outcome


Title	Number of Participants Who Had Anti-Lymphoma Activity
Description	Depending on the type of disease, we use PET/CT imaging, tumor biopsie...
Description	Depending on the type of disease, we use PET/CT imaging, tumor biopsies as well as bone marrow biopsies using immunohistochemistry and flow cytometry.
Time Frame	14 days up to 5 years post cell infusion.

Outcome Measure Data

Analysis Population Description


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Count of Participants Unit of Measure: Participants
	3 100.0%	2 100.0%	1 100.0%	2 50.0%	1 50.0%	6 66.7%

8.Secondary Outcome


Title	Number of Participants With Evidence of Immunogenicity of the Chimeric Antigen Receptor (CAR) T-cell Product
Description	Enzyme-linked spot (ELISPOT) assays were performed to look for anti-CA...
Description	Enzyme-linked spot (ELISPOT) assays were performed to look for anti-CAR T-cell responses.
Time Frame	9 days to 6 weeks after CAR T-cell infusion

Outcome Measure Data

Analysis Population Description


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0 Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0 Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0 Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

9.Other Pre-specified Outcome


Title	Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Description	Here is the number of participants with serious and non-serious advers...
Description	Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame	Date treatment consent signed to date off study, approximately 49 months and 19 days.

Outcome Measure Data

Analysis Population Description


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Count of Participants Unit of Measure: Participants
	3 100.0%	2 100.0%	1 100.0%	4 100.0%	2 100.0%	9 100.0%

10.Other Pre-specified Outcome


Title	MTD
Description	The maximum tolerated dose is the dose at which a maximum of 1 of 6 pa...
Description	The maximum tolerated dose is the dose at which a maximum of 1 of 6 patients has a dose limiting toxicity (DLT- Grade 3 toxicities possibly or probably related to toxicities possibly or probably related to either the anti-CD19 CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days . Grade 4 toxicities possibly or probably related to the study interventions.).
Time Frame	Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	All Participants
Arm/Group Description:	All participants who received Biolo...
Arm/Group Description:	All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Overall Number of Participants Analyzed	20
Measure Type: Number Unit of Measure: T-cells/kg
	NA ^[1]

[1]

The maximum tolerated dose for this protocol was not reached. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.

11.Other Pre-specified Outcome


Title	Number of Participants With a Dose-Limiting Toxicity (DLT)
Description	Number of participants with DLT's defined as follows: Grade 3 toxiciti...
Description	Number of participants with DLT's defined as follows: Grade 3 toxicities possibly or probably related to toxicities possibly or probably related to either the anti-CD19 CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions.
Time Frame	Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion

Outcome Measure Data

Analysis Population Description


Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description:	LEVEL 1 - participants who received...	LEVEL 1 followed by LEVEL 2 - parti...	LEVEL 1 followed by LEVEL 3 - parti...	LEVEL 2 - participants who received...	LEVEL 2 followed by LEVEL 3 - parti...	LEVEL 3 - participants who received...
Arm/Group Description:	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells	LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells	LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Overall Number of Participants Analyzed	3	2	1	4	2	9
Measure Type: Count of Participants Unit of Measure: Participants
	1 33.3%	0 0.0%	0 0.0%	2 50.0%	0 0.0%	1 11.1%

12.Other Pre-specified Outcome


Title	Maximum Feasible Dose
Description	Maximum feasible dose is the dose determined when the maximum tolerate...
Description	Maximum feasible dose is the dose determined when the maximum tolerated dose (MTD) cannot be reached.
Time Frame	Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion

Outcome Measure Data

Analysis Population Description


Arm/Group Title	All Participants
Arm/Group Description:	All participants who received Biolo...
Arm/Group Description:	All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Overall Number of Participants Analyzed	20
Measure Type: Number Unit of Measure: CAR+T cells/kg
	0.000006

Adverse Events

Time Frame	Date treatment consent signed to date off study, approximately 49 months and 19 days.
Adverse Event Reporting Description	6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.

Arm/Group Title	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only		LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells		LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only		LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
Arm/Group Description	LEVEL 1 - participants who received...		LEVEL 1 followed by LEVEL 2 - parti...		LEVEL 1 followed by LEVEL 3 - parti...		LEVEL 2 - participants who received...		LEVEL 2 followed by LEVEL 3 - parti...		LEVEL 3 - participants who received...
Arm/Group Description	LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only		LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells		LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells		LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only		LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells		LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
All-Cause Mortality
	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only		LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells		LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only		LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/3 (0.00%)		0/2 (0.00%)		0/1 (0.00%)		0/4 (0.00%)		0/2 (0.00%)		0/9 (0.00%)
Serious Adverse Events Serious Adverse Events
	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only		LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells		LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only		LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100.00%)		1/2 (50.00%)		1/1 (100.00%)		3/4 (75.00%)		1/2 (50.00%)		8/9 (88.89%)
Blood and lymphatic system disorders
Anemia ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	1/2 (50.00%)	1	0/9 (0.00%)	0
Cardiac disorders
Cardiac arrest ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Sinus tachycardia ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Endocrine disorders
Endocrine disorders - Other, specify ^† 1 [1]	0/3 (0.00%)	0	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Colitis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	2
Diarrhea ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	2/9 (22.22%)	2
Ileus ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
General disorders
Fever ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Infections and infestations
Appendicitis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Lung infection ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	2
Infections and infestations - Other, bacteremia b Fragilis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Investigations
Neutrophil count decreased ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Metabolism and nutrition disorders
Hyperglycemia ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Nervous system disorders
Encephalopathy ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Syncope ^† 1	2/3 (66.67%)	2	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Tremor ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Hypoxia ^† 1	0/3 (0.00%)	0	1/2 (50.00%)	2	0/1 (0.00%)	0	1/4 (25.00%)	2	0/2 (0.00%)	0	1/9 (11.11%)	2
Vascular disorders
Hematoma ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	3
Hypotension ^† 1	2/3 (66.67%)	2	1/2 (50.00%)	2	0/1 (0.00%)	0	2/4 (50.00%)	4	0/2 (0.00%)	0	1/9 (11.11%)	1
1 Term from vocabulary, CTCAE (5.0) † Indicates events were collected by systematic assessment [1] non-invasive follicular thyroid neoplasm with papillary-like nuclear features (nift)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only		LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells		LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only		LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells		LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100.00%)		2/2 (100.00%)		1/1 (100.00%)		4/4 (100.00%)		2/2 (100.00%)		9/9 (100.00%)
Blood and lymphatic system disorders
Anemia ^† 1	3/3 (100.00%)	9	2/2 (100.00%)	7	1/1 (100.00%)	6	3/4 (75.00%)	16	2/2 (100.00%)	7	9/9 (100.00%)	55
Cardiac disorders
Electrocardiogram QT corrected interval prolonged ^† 1	2/3 (66.67%)	3	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Pericardial effusion ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Sinus tachycardia ^† 1	1/3 (33.33%)	1	1/2 (50.00%)	2	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	4/9 (44.44%)	5
Supraventricular tachycardia ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Ear and labyrinth disorders
Ear pain ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/0	0	1/9 (11.11%)	2
Otitis media ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Endocrine disorders
Hypothyroidism ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Eye disorders
Conjunctivitis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/0	0	1/9 (11.11%)	1
Gastrointestinal disorders
Bloating ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Gastroesophageal reflux disease ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Nausea ^† 1	2/3 (66.67%)	3	1/2 (50.00%)	2	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	5/9 (55.56%)	6
Diarrhea ^† 1	0/3 (0.00%)	0	1/2 (50.00%)	1	1/1 (100.00%)	1	1/4 (25.00%)	1	0/2 (0.00%)	0	4/9 (44.44%)	9
Abdominal distension ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Abdominal pain ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	2/9 (22.22%)	4
Enterocolitis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Esophagitis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Upper gastrointestinal hemorrhage ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	1/1 (100.00%)	1	0/9 (0.00%)	0
Colitis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/0	0	1/9 (11.11%)	1
Constipation ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/0	0	2/9 (22.22%)	2
Ileus ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Vomiting ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
General disorders
Chills ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Fatigue ^† 1	1/3 (33.33%)	1	1/2 (50.00%)	1	1/1 (100.00%)	1	0/4 (0.00%)	0	1/2 (50.00%)	1	3/9 (33.33%)	4
Fever ^† 1	3/3 (100.00%)	8	1/2 (50.00%)	4	1/1 (100.00%)	2	3/4 (75.00%)	6	2/2 (100.00%)	2	9/9 (100.00%)	17
Neck edema ^† 1	0/3 (0.00%)	0	1/2 (50.00%)	1	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Headache ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	2
Localized edema ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Infections and infestations
Conjunctivitis infective ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Lung infection ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Mucosal infection ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Upper respiratory infection ^† 1	2/3 (66.67%)	5	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	3/9 (33.33%)	13
Skin infection ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	2
Infections and infestations - Other, Clostridium difficile ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	3/4 (75.00%)	3	0/2 (0.00%)	0	1/9 (11.11%)	1
Soft tissue infection ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Sinusitis ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	2/9 (22.22%)	2
Urinary tract infection ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	2/9 (22.22%)	4
Investigations
Activated partial thromboplastin time prolonged ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	2	0/2 (0.00%)	0	1/9 (11.11%)	3
Alanine aminotransferase increased ^† 1	2/3 (66.67%)	4	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	2/2 (100.00%)	3	1/9 (11.11%)	1
Aspartate aminotransferase increased ^† 1	3/3 (100.00%)	5	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	1/2 (50.00%)	2	1/9 (11.11%)	3
Lymphocyte count decreased ^† 1	3/3 (100.00%)	9	2/2 (100.00%)	17	1/1 (100.00%)	16	4/4 (100.00%)	14	2/2 (100.00%)	13	9/9 (100.00%)	43
Neutrophil count decreased ^† 1	3/3 (100.00%)	12	2/2 (100.00%)	10	1/1 (100.00%)	4	4/4 (100.00%)	12	2/2 (100.00%)	15	8/9 (88.89%)	100
White blood cell decreased ^† 1	3/3 (100.00%)	26	2/2 (100.00%)	12	1/1 (100.00%)	9	3/4 (75.00%)	15	2/2 (100.00%)	33	9/9 (100.00%)	101
Blood bilirubin increased ^† 1	0/3 (0.00%)	0	1/2 (50.00%)	3	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	2/9 (22.22%)	2
Platelet count decreased ^† 1	0/3 (0.00%)	0	1/2 (50.00%)	1	1/1 (100.00%)	1	2/4 (50.00%)	5	1/2 (50.00%)	2	7/9 (77.78%)	33
Fibrinogen decreased ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	3	0/2 (0.00%)	0	0/9 (0.00%)	0
Alkaline phosphatase increased ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	1/1 (100.00%)	2	0/9 (0.00%)	0
INR increased ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	1/1 (100.00%)	1	0/9 (0.00%)	0
Metabolism and nutrition disorders
Hypoalbuminemia ^† 1	2/3 (66.67%)	2	1/2 (50.00%)	2	1/1 (100.00%)	2	3/4 (75.00%)	5	1/2 (50.00%)	1	7/9 (77.78%)	19
Hyponatremia ^† 1	1/3 (33.33%)	5	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	2/9 (22.22%)	3
Hypophosphatemia ^† 1	2/3 (66.67%)	4	2/2 (100.00%)	7	0/1 (0.00%)	0	3/4 (75.00%)	11	2/2 (100.00%)	4	8/9 (88.89%)	47
Dehydration ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Hyperglycemia ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	2	0/2 (0.00%)	0	1/9 (11.11%)	2
Hypokalemia ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	2/4 (50.00%)	5	0/2 (0.00%)	0	2/9 (22.22%)	7
Hypermagnesemia ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Hypocalcemia ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	1/1 (100.00%)	1	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Bone pain ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Generalized muscle weakness ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Pain in extremity ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Mohs surgery ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Tumor pain ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Nervous system disorders
Presyncope ^† 1	1/3 (33.33%)	2	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Tremor ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Somnolence ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Psychiatric disorders
Confusion ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Delirium ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	1/9 (11.11%)	1
Renal and urinary disorders
Urinary retention ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	0/9 (0.00%)	0
Reproductive system and breast disorders
Vaginal dryness ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Erectile dysfunction ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/0	0	1/9 (11.11%)	1
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	1/3 (33.33%)	2	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	2/9 (22.22%)	5
Dyspnea ^† 1	2/3 (66.67%)	3	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	2/9 (22.22%)	2
Hiccups ^† 1	1/3 (33.33%)	2	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Hypoxia ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Nasal congestion ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Pleural effusion ^† 1	2/3 (66.67%)	2	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Hoarseness ^† 1	0/3 (0.00%)	0	1/2 (50.00%)	1	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Laryngeal edema ^† 1	0/3 (0.00%)	0	1/2 (50.00%)	1	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Sore throat ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	2/9 (22.22%)	2
Wheezing ^† 1	0/3 (0.00%)	0	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [1]	0/3 (0.00%)	0	0/2 (0.00%)	0	1/1 (100.00%)	1	0/4 (0.00%)	0	0/2 (0.00%)	0	0/9 (0.00%)	0
Vascular disorders
Hypertension ^† 1	1/3 (33.33%)	4	0/2 (0.00%)	0	0/1 (0.00%)	0	1/4 (25.00%)	1	0/2 (0.00%)	0	3/9 (33.33%)	10
Hypotension ^† 1	3/3 (100.00%)	3	1/2 (50.00%)	1	0/1 (0.00%)	0	1/4 (25.00%)	1	1/2 (50.00%)	1	2/9 (22.22%)	5
Thromboembolic event ^† 1	1/3 (33.33%)	1	0/2 (0.00%)	0	0/1 (0.00%)	0	0/4 (0.00%)	0	0/2 (0.00%)	0	1/9 (11.11%)	1
1 Term from vocabulary, CTCAE (5.0) † Indicates events were collected by systematic assessment [1] squamous cell carcinoma in situ removed from her right shoulder

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Dr. James N. Kochenderfer
Organization:	National Cancer Institute
Phone:	240-760-6062
EMail:	kochendj@nih.gov

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

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Responsible Party:	James Kochenderfer, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT02659943
Other Study ID Numbers:	160054 16-C-0054
First Submitted:	January 20, 2016
First Posted:	January 21, 2016
Results First Submitted:	February 22, 2021
Results First Posted:	May 4, 2021
Last Update Posted:	April 19, 2023

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