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: Active_not_recruiting
Location: See all (49) 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
Local Institution - 111
Santa Monica
Colorado
Local Institution - 107
Aurora
Connecticut
Local Institution - 105
New Haven
Iowa
Local Institution - 122
Iowa City
Illinois
Local Institution - 103
Chicago
Local Institution - 109
Niles
Kansas
Local Institution - 124
Wichita
Massachusetts
Local Institution - 100
Boston
Local Institution - 101
Boston
Maryland
Local Institution - 102
Baltimore
Michigan
Local Institution - 127
Detroit
North Carolina
Local Institution - 110
Charlotte
New Jersey
Local Institution - 123
Morristown
New York
Local Institution - 116
New York
Ohio
Local Institution - 112
Cleveland
Oregon
Local Institution - 114
Portland
Pennsylvania
Local Institution - 117
Philadelphia
South Dakota
Local Institution - 113
Sioux Falls
Texas
Local Institution - 121
Dallas
Local Institution - 104
Houston
Local Institution - 119
Houston
Virginia
Local Institution - 115
Charlottesville
Washington
Local Institution - 108
Seattle
Other Locations
Austria
Local Institution - 450
Vienna
Canada
Local Institution - 151
Montreal
Local Institution - 150
Toronto
France
Local Institution - 252
Lille
Local Institution - 251
Montpellier
Local Institution - 255
Paris
Local Institution - 250
Pierre-bénite
Local Institution - 253
Rennes
Local Institution - 254
Toulouse
Germany
Local Institution - 501
Cologne
Local Institution - 503
Karlsruhe
Local Institution - 502
Munich
Local Institution - 504
Regensburg
Local Institution - 500
Ulm
Italy
Local Institution - 300
Bergamo
Local Institution - 301
Naples
Japan
Local Institution - 550
Chuo-ku
Local Institution - 552
Fukuoka
Local Institution - 551
Minato-ku
Local Institution - 553
Sapporo
Spain
Local Institution - 353
Madrid
Local Institution - 350
Salamanca
Local Institution - 351
Seville
Sweden
Local Institution - 600
Stockholm
United Kingdom
Local Institution - 200
London
Local Institution - 201
Manchester
Time Frame
Start Date:2020-07-14
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.