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)
Who is this study for? Adult patients with Follicular Lymphoma or Marginal Zone Lymphoma
What treatments are being studied? CD4-Positive CAR-T Cells
Status: Recruiting
Location: See all (59) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
UCLA Medical Centre-Santa Monica
RECRUITING
Santa Monica
Colorado
University Of Colorado Cancer Center
RECRUITING
Aurora
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Florida
Local Institution - 0601
WITHDRAWN
Hollywood
Washington University School Of Medicine
WITHDRAWN
Miami
Iowa
University Of Iowa
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Local Institution - 109
COMPLETED
Niles
Kansas
Cancer Center of Kansas
RECRUITING
Wichita
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital - Dana-Farber Cancer Institute
RECRUITING
Boston
Maryland
University of Maryland - Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
Michigan
Karmanos Cancer Center
RECRUITING
Detroit
Local Institution - 118
WITHDRAWN
Detroit
North Carolina
Novant Health Presbyterian Medical Center
RECRUITING
Charlotte
North Dakota
Local Institution - 120
WITHDRAWN
Fargo
New Jersey
Atlantic Health System Morristown Medical Center
RECRUITING
Morristown
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Oregon
Providence Cancer Center/Earle A. Chiles Res. Inst.
RECRUITING
Portland
Pennsylvania
University of Pennsylvania - Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
Local Institution - 126
WITHDRAWN
Pittsburgh
South Dakota
Local Institution - 113
COMPLETED
Sioux Falls
Tennessee
Local Institution - 125
WITHDRAWN
Knoxville
Texas
Texas Oncology
RECRUITING
Dallas
Houston Methodist Hospital
RECRUITING
Houston
The University of Texas - MD Anderson Cancer Center
RECRUITING
Houston
Virginia
University Of Virginia Health System
RECRUITING
Charlottesville
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Austria
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
RECRUITING
Vienna
Canada
Hopital Maisonneuve - Rosemont
RECRUITING
Montreal
Princess Margaret Cancer Centre
RECRUITING
Toronto
France
CHRU-Hopital Claude Huriez
RECRUITING
Lille
CHU Montpellier - Hôpital Saint Eloi
RECRUITING
Montpellier
Hopital Saint Louis
RECRUITING
Paris
Centre Hospitalier Lyon-Sud
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
RECRUITING
Rennes
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
RECRUITING
Toulouse
Germany
Local Institution - 506
WITHDRAWN
Berlin
University Hospital Cologne
RECRUITING
Cologne
Stadtisches Klinikum Karlsruhe
RECRUITING
Karlsruhe
Local Institution - 505
WITHDRAWN
Kiel
LMU Klinikum der Universitat Munchen
RECRUITING
Munich
Universitätsklinikum Regensburg
RECRUITING
Regensburg
Universitaetsklinikum Ulm
RECRUITING
Ulm
Italy
Azienda Ospedaliera Papa Giovanni Xxiii
RECRUITING
Bergamo
Local Institution - 302
WITHDRAWN
Bologna
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
RECRUITING
Naples
Japan
Local Institution - 550
ACTIVE_NOT_RECRUITING
Chuo-ku
Local Institution - 552
COMPLETED
Fukuoka
Local Institution - 551
COMPLETED
Minato-ku
Local Institution - 553
ACTIVE_NOT_RECRUITING
Sapporo
Spain
Local Institution - 352
WITHDRAWN
Barcelona
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Virgen Del Rocio
RECRUITING
Seville
Sweden
Karolinska Hospital
RECRUITING
Stockholm
United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date:2020-07-14
Estimated Completion Date:2031-09-30
Participants
Target number of participants:276
Treatments
Experimental: Administration of JCAR017
* 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.