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

NCT04245839 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: JCAR017-FOL-001U1111-1244-97682024-510966-18
• Study Type: interventional
• Target: 276
• Locations: 10 countries
• Sites: 49

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.

Conditions

Lymphoma, Non-Hodgkin

Keywords

B-cell Non-Hodgkin Lymphoma (NHL); JCAR017; Relapsed or Refractory; Follicular Lymphoma; Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  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"

  Up to 60 months

Secondary Outcomes (11)

• Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"

  Up to 60 months

• Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"

  Up to 60 months

• Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"

  Up to 60 months

• Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"

  Up to 60 months

• Overall Survival (OS)

  Up to 60 months

Study Arms (1)

Administration of JCAR017

EXPERIMENTAL

* 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; Drug: Cyclophosphamide; Drug: JCAR017

Interventions

Fludarabine DRUG

Fludarabine

Administration of JCAR017

Cyclophosphamide DRUG

Cyclophosphamide

Administration of JCAR017

JCAR017 DRUG

JCAR017

Administration of JCAR017

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Celgene: lead

Study Sites (49)

Local Institution - 111

Santa Monica, California, 90095, United States

Location

Local Institution - 107

Aurora, Colorado, 80045, United States

Location

Local Institution - 105

New Haven, Connecticut, 06520, United States

Location

Local Institution - 103

Chicago, Illinois, 60611, United States

Location

Local Institution - 109

Niles, Illinois, 60714, United States

Location

Local Institution - 122

Iowa City, Iowa, 52242, United States

Location

Local Institution - 124

Wichita, Kansas, 67124, United States

Location

Local Institution - 102

Baltimore, Maryland, 21201, United States

Location

Local Institution - 100

Boston, Massachusetts, 02114, United States

Location

Local Institution - 101

Boston, Massachusetts, 02215, United States

Location

Local Institution - 127

Detroit, Michigan, 48201, United States

Location

Local Institution - 123

Morristown, New Jersey, 07960, United States

Location

Local Institution - 116

New York, New York, 10021, United States

Location

Local Institution - 110

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 112

Cleveland, Ohio, 44195, United States

Location

Local Institution - 114

Portland, Oregon, 97213, United States

Location

Local Institution - 117

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 113

Sioux Falls, South Dakota, 57105, United States

Location

Local Institution - 121

Dallas, Texas, 75230-2510, United States

Location

Local Institution - 104

Houston, Texas, 77030, United States

Location

Local Institution - 119

Houston, Texas, 77030, United States

Location

Local Institution - 115

Charlottesville, Virginia, 22903, United States

Location

Local Institution - 108

Seattle, Washington, 98109, United States

Location

Local Institution - 450

Vienna, 1090, Austria

Location

Local Institution - 150

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 151

Montreal, Quebec, H1T 2M4, Canada

Location

Local Institution - 252

Lille, 59037, France

Location

Local Institution - 251

Montpellier, 34295, France

Location

Local Institution - 255

Paris, 75475, France

Location

Local Institution - 250

Pierre-Bénite, 69495, France

Location

Local Institution - 253

Rennes, 35023, France

Location

Local Institution - 254

Toulouse, 31100, France

Location

Local Institution - 500

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Institution - 504

Regensburg, Bavaria, 93053, Germany

Location

Local Institution - 501

Cologne, 50937, Germany

Location

Local Institution - 503

Karlsruhe, 76135, Germany

Location

Local Institution - 502

Munich, 81377, Germany

Location

Local Institution - 300

Bergamo, 24127, Italy

Location

Local Institution - 301

Naples, 80131, Italy

Location

Local Institution - 553

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 550

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 551

Minato-ku, Tokyo, 105-8470, Japan

Location

Local Institution - 552

Fukuoka, 812-8582, Japan

Location

Local Institution - 353

Madrid, 28007, Spain

Location

Local Institution - 350

Salamanca, 37007, Spain

Location

Local Institution - 351

Seville, 41013, Spain

Location

Local Institution - 600

Stockholm, 14186, Sweden

Location

Local Institution - 200

London, NW1 2PG, United Kingdom

Location

Local Institution - 201

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• Morschhauser F, Dahiya S, Palomba ML, Martin Garcia-Sancho A, Reguera Ortega JL, Kuruvilla J, Jager U, Cartron G, Izutsu K, Dreyling M, Kahl B, Ghesquieres H, Ardeshna K, Goto H, Barbui AM, Abramson JS, Borchmann P, Fleury I, Mielke S, Skarbnik A, de Vos S, Kamdar M, Karmali R, Viardot A, Farazi T, Fasan O, Lymp J, Vedal M, Nishii R, Avilion A, Papuga J, Kumar J, Nastoupil LJ. Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study. Nat Med. 2024 Aug;30(8):2199-2207. doi: 10.1038/s41591-024-02986-9. Epub 2024 Jun 3.

  PMID: 38830991 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Recurrence; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: July 14, 2020
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (23); FR (6); AU (1); DE (5); ES (3); SE (1); IT (2); JP (4); CA (2); GB (2)