Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas

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ClinicalTrials.gov Identifier: NCT02030834

Recruitment Status : Completed

First Posted : January 9, 2014

Results First Posted : October 5, 2020

Last Update Posted : June 22, 2023

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Sponsor:

Information provided by (Responsible Party):

University of Pennsylvania

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Non-Hodgkins Lymphoma (NHL) Patients, With CD19+B Cell Lymphomas
Intervention	Biological: CART-19
Enrollment	63

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Cohort A	Cohort B	Cohort C
Arm/Group Description	murine CART19 ...	T cell/histiocyte-rich Diffuse Larg...	Diffuse Large B Cell Lymphoma (DLBC...
Arm/Group Description	murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
Period Title: Overall Study
Started	50	3	10
Completed	39	3	7
Not Completed	11	0	3
Reason Not Completed
Death	4	0	0
Manufacturing failure	2	0	1
Disease progression	2	0	2
Lost to Follow-up	1	0	0
Withdrawal by Subject	1	0	0
Lack of funding	1	0	0

Baseline Characteristics

Arm/Group Title		Cohort A	Cohort B	Cohort C	Total
Arm/Group Description		murine CART19 ...	T cell/histiocyte-rich Diffuse Larg...	Diffuse Large B Cell Lymphoma (DLBC...	Total of all reporting groups
Arm/Group Description		murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	Total of all reporting groups
Overall Number of Baseline Participants		50	3	10	63
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants	3 participants	10 participants	63 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	37 74.0%	2 66.7%	8 80.0%	47 74.6%
	>=65 years	13 26.0%	1 33.3%	2 20.0%	16 25.4%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants	3 participants	10 participants	63 participants
	Female	20 40.0%	1 33.3%	2 20.0%	23 36.5%
	Male	30 60.0%	2 66.7%	8 80.0%	40 63.5%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants	3 participants	10 participants	63 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	2 4.0%	0 0.0%	1 10.0%	3 4.8%
	Native Hawaiian or Other Pacific Islander	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%
	White	48 96.0%	3 100.0%	9 90.0%	60 95.2%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Number of Subjects With an Overall Response (i.e. Either Complete Response or Partial Response) Evaluated at Three Months Post Infusion.
Description	Responders will include those patients achieving complete response (CR...
Description	Responders will include those patients achieving complete response (CR), complete response unconfirmed (CRu) and partial response (PR) using anatomic imaging such as CT or MRI to assess tumor volume or, in the event of bone marrow involvement, morphologic and immunohistochemical confirmation that the bone marrow infiltrate has been cleared.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Cohort A	Cohort B	Cohort C
Arm/Group Description:	murine CART19 ...	T cell/histiocyte-rich Diffuse Larg...	Diffuse Large B Cell Lymphoma (DLBC...
Arm/Group Description:	murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
Overall Number of Participants Analyzed	39	3	7
Measure Type: Count of Participants Unit of Measure: Participants
	24 61.5%	1 33.3%	1 14.3%

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Cohort A	Cohort B	Cohort C
Arm/Group Description	murine CART19 ...	T cell/histiocyte-rich Diffuse Larg...	Diffuse Large B Cell Lymphoma (DLBC...
Arm/Group Description	murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	T cell/histiocyte-rich Diffuse Large B Cell Lymphoma (DLBCL) treated with murine CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).	Diffuse Large B Cell Lymphoma (DLBCL) treated with humanized CART19 CART-19: Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
All-Cause Mortality
	Cohort A	Cohort B	Cohort C
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/50 (10.00%)	0/3 (0.00%)	2/10 (20.00%)
Serious Adverse Events Serious Adverse Events
	Cohort A	Cohort B	Cohort C
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	32/50 (64.00%)	3/3 (100.00%)	5/10 (50.00%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	3/50 (6.00%)	0/3 (0.00%)	1/10 (10.00%)
Cardiac disorders
Sinus tachycardia ^† 1	1/50 (2.00%)	2/3 (66.67%)	0/10 (0.00%)
Supraventricular tachycardia ^† 1	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
Eye disorders
Eye disorders - Other, specify ^† 1 [1]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify ^† 1 [2]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
General disorders
Fever ^† 1	6/50 (12.00%)	1/3 (33.33%)	0/10 (0.00%)
Pain ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Immune system disorders
Allergic reaction ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Cytokine release syndrome ^† 1	20/50 (40.00%)	2/3 (66.67%)	4/10 (40.00%)
Infections and infestations
Enterocolitis infectious ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [3]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [4]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Lung infection ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Sepsis ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Sinusitis ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Upper respiratory infection ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Metabolism and nutrition disorders
Hypercalcemia ^† 1	0/50 (0.00%)	0/3 (0.00%)	1/10 (10.00%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome ^* 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1 [5]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Nervous system disorders
Encephalopathy ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Syncope ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Hematuria ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders
Aspiration ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Hypoxia ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Pleural effusion ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Vascular disorders
Hematoma ^† 1	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
Hypotension ^† 1	2/50 (4.00%)	1/3 (33.33%)	0/10 (0.00%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment [1] Scotoma left eye [2] Incarcerated umbilical hernia [3] Influenza A [4] Streptococcal Bacteremia * Indicates events were collected by non-systematic assessment [5] Second primary cancer
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Cohort A	Cohort B	Cohort C
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	39/50 (78.00%)	3/3 (100.00%)	7/10 (70.00%)
Blood and lymphatic system disorders
Anemia ^† 1	14/50 (28.00%)	1/3 (33.33%)	1/10 (10.00%)
Blood and lymphatic system disorders - Other, specify ^† 1 [1]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Febrile neutropenia ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Thrombotic thrombocytopenic purpura ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Diarrhea ^† 1	8/50 (16.00%)	2/3 (66.67%)	2/10 (20.00%)
Cardiac disorders
Atrial fibrillation ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Cardiac arrest ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Chest pain - cardiac ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Restrictive cardiomyopathy ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Sick sinus syndrome ^† 1	0/50 (0.00%)	0/3 (0.00%)	1/10 (10.00%)
Sinus tachycardia ^† 1	8/50 (16.00%)	0/3 (0.00%)	0/10 (0.00%)
Ear and labyrinth disorders
Hearing impaired ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Vertigo ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Endocrine disorders
Hypothyroidism ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Eye disorders
Blurred vision ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Conjunctivitis ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Eye disorders - Other, specify ^† 1 [2]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Flashing lights ^† 1	0/50 (0.00%)	0/3 (0.00%)	1/10 (10.00%)
Floaters ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Optic nerve disorder ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Photophobia ^† 1	0/50 (0.00%)	0/3 (0.00%)	1/10 (10.00%)
Gastrointestinal disorders
Abdominal distension ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Abdominal pain ^† 1	6/50 (12.00%)	2/3 (66.67%)	0/10 (0.00%)
Constipation ^† 1	9/50 (18.00%)	1/3 (33.33%)	1/10 (10.00%)
Dyspepsia ^† 1	0/50 (0.00%)	0/3 (0.00%)	2/10 (20.00%)
Dysphagia ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Enterocolitis ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Flatulence ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Gastroesophageal reflux disease ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Gastrointestinal disorders - Other, specify ^† 1 [3]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Intra-abdominal hemorrhage ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Mucositis oral ^† 1	3/50 (6.00%)	1/3 (33.33%)	0/10 (0.00%)
Nausea ^† 1	7/50 (14.00%)	2/3 (66.67%)	3/10 (30.00%)
Small intestinal obstruction ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Vomiting ^† 1	5/50 (10.00%)	1/3 (33.33%)	1/10 (10.00%)
Gastrointestinal disorders - Other, specify ^† 1 [4]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Edema limbs ^† 1	8/50 (16.00%)	1/3 (33.33%)	1/10 (10.00%)
Edema trunk ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
General disorders
Chills ^† 1	0/50 (0.00%)	1/3 (33.33%)	1/10 (10.00%)
Fatigue ^† 1	23/50 (46.00%)	2/3 (66.67%)	3/10 (30.00%)
Fever ^† 1	5/50 (10.00%)	0/3 (0.00%)	2/10 (20.00%)
General disorders and administration site conditions - Other, specify ^† 1 [5]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Localized edema ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Non-cardiac chest pain ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Pain ^† 1	7/50 (14.00%)	1/3 (33.33%)	2/10 (20.00%)
Immune system disorders
Allergic reaction ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations
Abdominal infection ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Bronchial infection ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Gum infection ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [6]	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [7]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [8]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [9]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [10]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [11]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Infections and infestations - Other, specify ^† 1 [12]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Lung infection ^† 1	2/50 (4.00%)	0/3 (0.00%)	1/10 (10.00%)
Mucosal infection ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Otitis media ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Papulopustular rash ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Rash pustular ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Sinusitis ^† 1	3/50 (6.00%)	0/3 (0.00%)	1/10 (10.00%)
Skin infection ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Small intestine infection ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Upper respiratory infection ^† 1	10/50 (20.00%)	1/3 (33.33%)	0/10 (0.00%)
Urinary tract infection ^† 1	4/50 (8.00%)	0/3 (0.00%)	0/10 (0.00%)
Vaginal infection ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify ^† 1 [13]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	11/50 (22.00%)	1/3 (33.33%)	1/10 (10.00%)
Alkaline phosphatase increased ^† 1	1/50 (2.00%)	1/3 (33.33%)	0/10 (0.00%)
Aspartate aminotransferase increased ^† 1	10/50 (20.00%)	3/3 (100.00%)	3/10 (30.00%)
Blood bilirubin increased ^† 1	6/50 (12.00%)	0/3 (0.00%)	0/10 (0.00%)
CD4 lymphocytes decreased ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Cholesterol high ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Creatinine increased ^† 1	6/50 (12.00%)	1/3 (33.33%)	1/10 (10.00%)
Fibrinogen decreased ^† 1	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
Investigations - Other, specify ^† 1 [14]	0/50 (0.00%)	0/3 (0.00%)	1/10 (10.00%)
Lymphocyte count decreased ^† 1	7/50 (14.00%)	0/3 (0.00%)	2/10 (20.00%)
Lymphocyte count increased ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Neutrophil count decreased ^† 1	19/50 (38.00%)	2/3 (66.67%)	5/10 (50.00%)
Platelet count decreased ^† 1	10/50 (20.00%)	2/3 (66.67%)	1/10 (10.00%)
Weight gain ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Weight loss ^† 1	4/50 (8.00%)	0/3 (0.00%)	0/10 (0.00%)
White blood cell decreased ^† 1	13/50 (26.00%)	1/3 (33.33%)	3/10 (30.00%)
Metabolism and nutrition disorders
Acidosis ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Anorexia ^† 1	4/50 (8.00%)	1/3 (33.33%)	2/10 (20.00%)
Dehydration ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Hypercalcemia ^† 1	2/50 (4.00%)	0/3 (0.00%)	1/10 (10.00%)
Hyperglycemia ^† 1	11/50 (22.00%)	0/3 (0.00%)	1/10 (10.00%)
Hyperkalemia ^† 1	0/50 (0.00%)	1/3 (33.33%)	1/10 (10.00%)
Hypermagnesemia ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Hypoalbuminemia ^† 1	12/50 (24.00%)	1/3 (33.33%)	2/10 (20.00%)
Hypocalcemia ^† 1	16/50 (32.00%)	3/3 (100.00%)	2/10 (20.00%)
Hypoglycemia ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Hypokalemia ^† 1	13/50 (26.00%)	1/3 (33.33%)	0/10 (0.00%)
Hypomagnesemia ^† 1	10/50 (20.00%)	1/3 (33.33%)	1/10 (10.00%)
Hyponatremia ^† 1	18/50 (36.00%)	2/3 (66.67%)	2/10 (20.00%)
Hypophosphatemia ^† 1	12/50 (24.00%)	2/3 (66.67%)	0/10 (0.00%)
Iron overload ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	6/50 (12.00%)	1/3 (33.33%)	0/10 (0.00%)
Back pain ^† 1	8/50 (16.00%)	0/3 (0.00%)	1/10 (10.00%)
Flank pain ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Joint range of motion decreased ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Muscle weakness lower limb ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1 [15]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1 [16]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1 [17]	1/50 (2.00%)	1/3 (33.33%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1 [18]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1 [19]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1 [20]	0/50 (0.00%)	0/3 (0.00%)	1/10 (10.00%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1 [21]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Myalgia ^† 1	3/50 (6.00%)	2/3 (66.67%)	2/10 (20.00%)
Neck pain ^† 1	2/50 (4.00%)	0/3 (0.00%)	1/10 (10.00%)
Osteoporosis ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Pain in extremity ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1 [22]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1 [23]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1 [24]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Nervous system disorders
Cognitive disturbance ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Dizziness ^† 1	4/50 (8.00%)	0/3 (0.00%)	1/10 (10.00%)
Dysgeusia ^† 1	1/50 (2.00%)	0/3 (0.00%)	1/10 (10.00%)
Headache ^† 1	11/50 (22.00%)	1/3 (33.33%)	3/10 (30.00%)
Hydrocephalus ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Memory impairment ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Movements involuntary ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Nervous system disorders - Other, specify ^† 1 [25]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Paresthesia ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Peripheral motor neuropathy ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Spasticity ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Tremor ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Psychiatric disorders
Anxiety ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Confusion ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Delirium ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Hallucinations ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Insomnia ^† 1	2/50 (4.00%)	1/3 (33.33%)	0/10 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Renal and urinary disorders - Other, specify ^† 1 [26]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Renal and urinary disorders - Other, specify ^† 1 [27]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Renal and urinary disorders - Other, specify ^* 1 [28]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Urinary frequency ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Urinary urgency ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Reproductive system and breast disorders
Genital edema ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Perineal pain ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Aspiration ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Atelectasis ^† 1	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
Bronchial stricture ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Cough ^† 1	7/50 (14.00%)	1/3 (33.33%)	0/10 (0.00%)
Dyspnea ^† 1	3/50 (6.00%)	1/3 (33.33%)	0/10 (0.00%)
Hoarseness ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Hypoxia ^† 1	2/50 (4.00%)	1/3 (33.33%)	0/10 (0.00%)
Laryngeal edema ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Nasal congestion ^† 1	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Pleural effusion ^† 1	2/50 (4.00%)	1/3 (33.33%)	0/10 (0.00%)
Pneumonitis ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Postnasal drip ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Pulmonary edema ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders - Other, specify ^† 1 [29]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders - Other, specify ^† 1 [30]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders - Other, specify ^† 1 [31]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Retinoic acid syndrome ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Sleep apnea ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	2/50 (4.00%)	0/3 (0.00%)	1/10 (10.00%)
Erythema multiforme ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Erythroderma ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Pruritus ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Purpura ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Rash acneiform ^† 1	0/50 (0.00%)	0/3 (0.00%)	1/10 (10.00%)
Rash maculo-papular ^† 1	1/50 (2.00%)	1/3 (33.33%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [32]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [33]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [34]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [35]	1/50 (2.00%)	1/3 (33.33%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [36]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [37]	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [38]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [39]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [40]	3/50 (6.00%)	0/3 (0.00%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [41]	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders - Other, specify ^† 1 [42]	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
Skin ulceration ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Hypotension ^† 1	6/50 (12.00%)	0/3 (0.00%)	0/10 (0.00%)
Vascular disorders
Hot flashes ^† 1	2/50 (4.00%)	1/3 (33.33%)	0/10 (0.00%)
Hypertension ^† 1	4/50 (8.00%)	0/3 (0.00%)	0/10 (0.00%)
Lymphedema ^† 1	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Thromboembolic event ^† 1	2/50 (4.00%)	0/3 (0.00%)	0/10 (0.00%)
Vascular disorders - Other, specify ^† 1 [43]	1/50 (2.00%)	0/3 (0.00%)	0/10 (0.00%)
Vascular disorders - Other, specify ^† 1 [36]	1/50 (2.00%)	1/3 (33.33%)	1/10 (10.00%)
Vascular disorders - Other, specify ^† 1 [44]	0/50 (0.00%)	1/3 (33.33%)	0/10 (0.00%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment [1] Splenomegaly [2] Fogginess [3] Barrett's Esophagus [4] White on tongue [5] Rigors [6] Giardia in stool [7] Bronchiolitis [8] Clostridium difficile [9] flu [10] Lymphadenitis: inguinal [11] Upper Respiratory Infection [12] UTI [13] Head Laceration [14] Headache [15] Body aches in joints and muscles [16] Calcium Pyrophosphate Deposition Disease [17] Cramps [18] Lateral epicondylitis [19] Muscular atrophy [20] Labral tear [21] Twitching: finger [22] Basal cell carcinoma [23] Melanoma (T1A) [24] Squamous cell carcinoma [25] Tingling [26] Hydroureteronephrosis [27] Urinary hesitancy * Indicates events were collected by non-systematic assessment [28] Urine: foamy [29] Lungs: decreased breath sounds [30] Lungs: crackles [31] Morning cough and sputum production [32] Actinic keratosis [33] Bloody lips [34] Contact dermatitis [35] Erythematous rash [36] Night sweats [37] Rash [38] Skin excoriation [39] Verruca vulgaris [40] Warts [41] Vescular rash [42] Folliculitis [43] Fluid overload [44] Livedo reticularis

Limitations and Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

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Name/Title:	Regulatory Lead
Organization:	University of Pennsylvania
Phone:	215-662-4484
EMail:	psom-ind-ide@pobox.upenn.edu

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.

Schuster SJ, Svoboda J, Chong EA, Nasta SD, Mato AR, Anak O, Brogdon JL, Pruteanu-Malinici I, Bhoj V, Landsburg D, Wasik M, Levine BL, Lacey SF, Melenhorst JJ, Porter DL, June CH. Chimeric Antigen Receptor T Cells in Refractory B-Cell Lymphomas. N Engl J Med. 2017 Dec 28;377(26):2545-2554. doi: 10.1056/NEJMoa1708566. Epub 2017 Dec 10.

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Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT02030834
Other Study ID Numbers:	UPCC 13413, 818607
First Submitted:	January 7, 2014
First Posted:	January 9, 2014
Results First Submitted:	September 9, 2020
Results First Posted:	October 5, 2020
Last Update Posted:	June 22, 2023

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