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

Last updated: April 28, 2025
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma, B-cell

Lymphoma

Treatment

Fludarabine

JCAR017

Cyclophosphamide

Clinical Study ID

NCT04245839
JCAR017-FOL-001
2024-510966-18
U1111-1244-9768
2019-004081-18
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zonelymphoma (MZL) histologically confirmed within 6 months of screening, as assessed bylocal pathology

  2. Patients should have received at least one prior therapy that includes anti-CD20 andalkylating 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 theypresent with high risk features. Patients that received two or more prior lines ofsystemic therapy are eligible, assuming one of the prior lines includes anti-CD20and alkylating agent (as listed in criterion 2)

  4. Marginal zone lymphoma patients: Received two or more prior lines of systemictherapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (aslisted 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

Exclusion Criteria:

  1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or oftransformed FL

  2. WHO subclassification of duodenal-type FL

  3. Central nervous system-only involvement by malignancy (subjects with secondarycentral nervous system (CNS) involvement are allowed on study)

  4. History of another primary malignancy that has not been in remission for at least 2years, 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 despiteappropriate 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 ofleukapheresis

Study Design

Total Participants: 276
Treatment Group(s): 3
Primary Treatment: Fludarabine
Phase: 2
Study Start date:
July 14, 2020
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • Local Institution - UNK-201

    Salzburg, 5020
    Austria

    Site Not Available

  • Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien

    Wien, 1090
    Austria

    Active - Recruiting

  • Local Institution - 450

    Wien, 1090
    Austria

    Site Not Available

  • Local Institution - 150

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Hopital Maisonneuve - Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • Local Institution - 151

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Ontario, Toronto M5G 2M9
    Canada

    Site Not Available

  • CIUSSS de l'Est-de-l'Ile-de-Montreal - Installation Hopital Maisonneuve-Rosemont

    Quebec,
    Canada

    Site Not Available

  • CHRU-Hopital Claude Huriez

    Lille, 59037
    France

    Active - Recruiting

  • Local Institution - 252

    Lille, 59037
    France

    Site Not Available

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier, 34295
    France

    Site Not Available

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier CEDEX 5, 34295
    France

    Active - Recruiting

  • Local Institution - 251

    Montpellier CEDEX 5, 34295
    France

    Site Not Available

  • Hopital Saint Louis

    Paris Cedex 10, 75475
    France

    Active - Recruiting

  • Local Institution - 255

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Centre Hospitalier Lyon-Sud

    Pierre-Benite, 69495
    France

    Site Not Available

  • Centre Hospitalier Lyon-Sud

    Pierre-Benite CEDEX, 69495
    France

    Active - Recruiting

  • Local Institution - 250

    Pierre-Benite CEDEX, 69495
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes Cedex 02, 35023
    France

    Active - Recruiting

  • Local Institution - 253

    Rennes Cedex 02, 35023
    France

    Site Not Available

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

    Toulouse, 31100
    France

    Active - Recruiting

  • Local Institution - 254

    Toulouse, 31100
    France

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg 89081
    Germany

    Active - Recruiting

  • Local Institution - 504

    Regensburg, Bayern 93053
    Germany

    Site Not Available

  • Local Institution - 506

    Berlin, 12203
    Germany

    Site Not Available

  • Local Institution - 503

    Karlsruhe, 76135
    Germany

    Site Not Available

  • Local Institution - 505

    Kiel, 24105
    Germany

    Site Not Available

  • Local Institution - 501

    Koeln, 50937
    Germany

    Site Not Available

  • Local Institution - 501

    Köln, 50937
    Germany

    Site Not Available

  • University Hospital Cologne

    Köln, 50937
    Germany

    Active - Recruiting

  • LMU Klinikum der Universitat Munchen

    Munich, 81377
    Germany

    Active - Recruiting

  • Local Institution - 502

    Munich, 81377
    Germany

    Site Not Available

  • Local Institution - 500

    Ulm, 89081
    Germany

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni Xxiii

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Local Institution - 300

    Bergamo, 24127
    Italy

    Site Not Available

  • Local Institution - 302

    Bologna, 40138
    Italy

    Site Not Available

  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

    Naples, 80131
    Italy

    Active - Recruiting

  • Local Institution - 301

    Naples, 80131
    Italy

    Site Not Available

  • Local Institution - 553

    Sapporo-shi, Hokkaido 0608648
    Japan

    Site Not Available

  • Local Institution - 550

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Local Institution - 551

    Minato-ku, Tokyo 105-8470
    Japan

    Completed

  • Local Institution - 552

    Fukuoka, 812-8582
    Japan

    Completed

  • Local Institution - 553

    Sapporo, Hokkaidô, 060-8648
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo-shi, Hokkaido, 060-8648
    Japan

    Site Not Available

  • Local Institution - 352

    Barcelona, 8035
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Local Institution - 353

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Local Institution - 350

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Local Institution - 351

    Sevilla, 41013
    Spain

    Site Not Available

  • Karolinska Hospital

    Stockholm, 14186
    Sweden

    Active - Recruiting

  • Local Institution - 600

    Stockholm, 14186
    Sweden

    Site Not Available

  • Local Institution - 200

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Local Institution - 201

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Withington, M20 4BX
    United Kingdom

    Site Not Available

  • Local Institution - 111

    Santa Monica, California 90095
    United States

    Site Not Available

  • UCLA Medical Centre-Santa Monica

    Santa Monica, California 90095
    United States

    Active - Recruiting

  • Local Institution - 107

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University Of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Local Institution - 105

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Local Institution - 0601

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Local Institution - 125

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Washington University School Of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Local Institution - 103

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Illinois Cancer Specialists

    Niles, Illinois 60714
    United States

    Active - Recruiting

  • Local Institution - 109

    Niles, Illinois 60714
    United States

    Completed

  • Local Institution - 122

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University Of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Cancer Center of Kansas

    Wichita, Kansas 67124
    United States

    Active - Recruiting

  • Local Institution - 124

    Wichita, Kansas 67124
    United States

    Site Not Available

  • Local Institution - 102

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Maryland - Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Local Institution - 100

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Local Institution - 101

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital - Dana-Farber Cancer Institute

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University Of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109-5936
    United States

    Site Not Available

  • Karmanos Cancer Center

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Local Institution - 118

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Local Institution - 123

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Local Institution - 116

    New York, New York 10021
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • Local Institution - 110

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Local Institution - 120

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Local Institution - 112

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 114

    Portland, Oregon 97213
    United States

    Site Not Available

  • Providence Cancer Center/Earle A. Chiles Res. Inst.

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Local Institution - 117

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania - Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Local Institution - 126

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Local Institution - 113

    Sioux Falls, South Dakota 57105
    United States

    Completed

  • Local Institution - 125

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Local Institution - 126

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Local Institution - 121

    Dallas, Texas 75230-2510
    United States

    Site Not Available

  • Local Institution - 104

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 119

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Local Institution - 115

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University Of Virginia Health System

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Fred Hutchinson.Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Local Institution - 108

    Seattle, Washington 98109
    United States

    Site Not Available

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