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NCT04245839

PHASE2

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

Sponsor: Celgene

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2020-07-14

Completion Date

2031-09-30

Last Updated

2025-11-05

Healthy Volunteers

Conditions

Lymphoma, Non-Hodgkin

Interventions

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

JCAR017

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

Locations (49)

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

Local Institution - 151

Montreal, Quebec, Canada

Local Institution - 252

Lille, France

Local Institution - 251

Montpellier, France

Local Institution - 255

Paris, France

Local Institution - 250

Pierre-Bénite, France

Local Institution - 253

Rennes, France

Local Institution - 254

Toulouse, France

Local Institution - 500

Ulm, Baden-Wurttemberg, Germany

Local Institution - 504

Regensburg, Bavaria, Germany

Local Institution - 501

Cologne, Germany

Local Institution - 503

Karlsruhe, Germany

Local Institution - 502

Munich, Germany

Local Institution - 300

Bergamo, Italy

Local Institution - 301

Naples, Italy

Local Institution - 553

Sapporo, Hokkaido, Japan

Local Institution - 550

Chuo-ku, Tokyo, Japan

Local Institution - 551

Minato-ku, Tokyo, Japan

Local Institution - 552

Fukuoka, Japan

Local Institution - 353

Madrid, Spain

Local Institution - 350

Salamanca, Spain

Local Institution - 351

Seville, Spain

Local Institution - 600

Stockholm, Sweden

Local Institution - 200

London, United Kingdom

Local Institution - 201

Manchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)