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A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245839
Recruitment Status : Active, not recruiting
First Posted : January 29, 2020
Last Update Posted : November 30, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

  • Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
  • Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
  • Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Fludarabine Drug: Cyclophosphamide Drug: JCAR017 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : September 28, 2028
Estimated Study Completion Date : September 28, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Administration of JCAR017
  • Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents.
  • JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
 Drug: Fludarabine
Fludarabine

Drug: Cyclophosphamide
Cyclophosphamide

Drug: JCAR017
JCAR017


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 60 months ]
    Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"


Secondary Outcome Measures :
  1. Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 60 months ]
    Is defined as the percentage of subjects achieving a CR at any time up to 60 months after JCAR017 treatment

  2. Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 60 months ]
    is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 60 months after JCAR017 treatment

  3. Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 60 months ]
    is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment

  4. Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 60 months ]
    is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment

  5. Overall Survival (OS) [ Time Frame: Up to 60 months ]
    is defined as the time from start of JCAR017 to time of death due to any cause up to 60 months after JCAR017 treatment

  6. Adverse Events (AEs) [ Time Frame: Up to 60 months ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

  7. Pharmacokinetics - Cmax [ Time Frame: Up to 60 months ]
    Maximum concentration

  8. Pharmacokinetics - Tmax [ Time Frame: Up to 60 months ]
    Time to maximum concentration

  9. Pharmacokinetics - AUC [ Time Frame: Up to 60 months ]
    Area under the curve

  10. European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) [ Time Frame: Up to 24 months ]

    is questionnaire that will be used as a measure of health-related quality of life.

    The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.


  11. Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS) [ Time Frame: Up to 24 months ]
    is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. High scores indicate lower symptom burden.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
  2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
  3. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
  4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate organ function
  7. Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

  1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
  2. WHO subclassification of duodenal-type FL
  3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
  4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
  5. Prior CAR T-cell or other genetically-modified cell therapy
  6. History of or active human immunodeficiency virus (HIV)
  7. Active hepatitis B or active hepatitis C
  8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
  9. Active autoimmune disease requiring immunosuppressive therapy
  10. Presence of acute or chronic graft-versus-host=disease
  11. History of significant cardiovascular disease
  12. History or presence of clinically relevant central nervous system pathology
  13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245839


Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04245839    
Other Study ID Numbers: JCAR017-FOL-001
U1111-1244-9768 ( Other Identifier: WHO )
2019-004081-18 ( EudraCT Number )
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: November 30, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
B-cell Non-Hodgkin Lymphoma (NHL)
JCAR017
Relapsed or Refractory
Follicular Lymphoma
Marginal Zone Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
 Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists