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)

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Celgene

Status and phase

Active, not recruiting
Phase 2

Conditions

Lymphoma, Non-Hodgkin

Treatments

Drug: Fludarabine
Drug: JCAR017
Drug: Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04245839
2019-004081-18 (EudraCT Number)
JCAR017-FOL-001
U1111-1244-9768 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

213 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

213 participants in 1 patient group

Administration of JCAR017
Experimental group
Description:
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.
Treatment:
Drug: Cyclophosphamide
Drug: JCAR017
Drug: Fludarabine

Trial contacts and locations

38

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Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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