NCT04245839
Recruiting
January 29, 2020
November 16, 2021
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 2 years.
N/A
Arm | Intervention/treatment |
---|---|
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 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 Fludarabine Drug: Cyclophosphamide Cyclophosphamide Drug: JCAR017 JCAR017 |
Inclusion Criteria: 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 Exclusion Criteria: 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
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, California
UCLA Medical Centre-Santa Monica
Santa Monica
United States, Colorado
University of Colorado Cancer Center
Aurora
United States, Connecticut
Yale New Haven Health - Smilow Cancer Hospita
New Haven
United States, Illinois
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Chicago
United States, Illinois
Illinois Cancer Specialists - Arlington Heights
Niles
United States, Maryland
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore
United States, Massachusetts
Massachusetts General Hospital - Dana-Farber Cancer Institute (The Jon and JoAnn Hagler Center for Lymphoma)
Boston
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston
United States, New York
Memorial Sloan Kettering Cancer Center
New York
United States, North Carolina
Novant Health Cancer Specialists Charlotte
Charlotte
United States, Ohio
Cleveland Clinic - Taussig Cancer Institute
Cleveland
United States, Oregon
Providence Cancer Center - Earle A. Chiles Research Institute
Portland
United States, Pennsylvania
Perelman Center for Advanced Medicine - Abramson Cancer Center University of Pennsylvania
Philadelphia
United States, South Dakota
Avera Research Institute
Sioux Falls
United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston
United States, Virginia
University of Virginia Health System
Charlottesville
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle
Austria
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
Wien
Canada, Montreal
Hospital Maisonneuve - Rosemont
Quebec
Canada, Toronto
Princess Margaret Cancer Centre
Ontario
Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal - Installation Hopital Maisonneuve-Rosemont
Quebec
France
CHRU-Hopital Claude Huriez
Lille
France
CHU Montpellier - Hôpital Saint Eloi
Montpellier
France
Centre Hospitalier Lyon-Sud
Pierre-Benite
Germany
Universitatsklinikum Koeln
Koeln
Germany
LMU Klinikum der Universitat Muenchen
Munich
Germany
Universitaetsklinikum Ulm
Ulm
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples
Japan
National Cancer Center Hospital
Chuo-ku
Japan
Kyushu University Hospital
Fukuoka
Japan
Toranomon Hospital
Minato-ku
Japan
Hokkaido University Hospital
Sapporo-shi, Hokkaido
Spain
Universitario de Salamanca - Hospital Clinico
Salamanca
Spain
Hospital Universitario Virgen del Rocio
Sevilla
Sweden
Karolinska University Hospital
Stockholm
United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London
United Kingdom
The Christie NHS Foundation Trust
Withington
Celgene
Study Director: Thalia Farazi, M.D./Ph.D Celgene Medical Director