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

Running, not enrolling · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID: NCT04245839
Run by: Celgene
People needed: 276
Starts: 2020-07-14
Expected to finish: 2031-09-30
Last updated by the study team: 2025-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
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)
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Adequate vascular access for leukapheresis procedure

You may not qualify if…

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

Where it is running

Local Institution - 111 — Santa Monica, California, United States
Local Institution - 107 — Aurora, Colorado, United States
Local Institution - 105 — New Haven, Connecticut, United States
Local Institution - 103 — Chicago, Illinois, United States
Local Institution - 109 — Niles, Illinois, United States
Local Institution - 122 — Iowa City, Iowa, United States
Local Institution - 124 — Wichita, Kansas, United States
Local Institution - 102 — Baltimore, Maryland, United States
Local Institution - 100 — Boston, Massachusetts, United States
Local Institution - 101 — Boston, Massachusetts, United States
Local Institution - 127 — Detroit, Michigan, United States
Local Institution - 123 — Morristown, New Jersey, United States
Local Institution - 116 — New York, New York, United States
Local Institution - 110 — Charlotte, North Carolina, United States
Local Institution - 112 — Cleveland, Ohio, United States
Local Institution - 114 — Portland, Oregon, United States
Local Institution - 117 — Philadelphia, Pennsylvania, United States
Local Institution - 113 — Sioux Falls, South Dakota, United States
Local Institution - 121 — Dallas, Texas, United States
Local Institution - 104 — Houston, Texas, United States
Local Institution - 119 — Houston, Texas, United States
Local Institution - 115 — Charlottesville, Virginia, United States
Local Institution - 108 — Seattle, Washington, United States
Local Institution - 450 — Vienna, Austria
Local Institution - 150 — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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