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Recruiting

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) - JCAR017-FOL-001

Updated: 3 August, 2021   |   ClinicalTrials.gov

Juno Therapeutics and Celgene are wholly owned subsidiaries of Bristol-Myers Squibb Company

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 24

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Administration of JCAR017
Drug: Fludarabine Drug: JCAR017 Drug: Cyclophosphamide

Key Eligibility 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com