Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
Start Date
3/11/2019
Completion Date
6/1/2027
Summary
This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.
Detailed Description
This is a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and tolerability, find an appropriate dose to optimize safety and efficacy, and evaluate clinical activity of azer-cel in participants with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL), non-Hodgkin lymphoma (NHL), and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Before initiating azer-cel, participants will be administered lymphodepletion (LD). At Day 0 of the Treatment Period, participants will receive an intravenous (IV) infusion of azer-cel potentially followed by interleukin-2 (IL-2). All participants will be monitored through D720 or progression. All participants who receive a dose of azer-cel will be asked to consent to a separate long-term follow-up (LTFU) study for up to 15 years after exiting this study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Azer-cel
Fludarabine
Cyclophosphamide
IL-2
Conditions
Locations
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
City of Hope
Duarte, California 91010
United States
H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United States
Winship Cancer Institute Emory University
Atlanta, Georgia 30322
United States
Northside Hospital Cancer Institute
Atlanta, Georgia 30342
United States
University of Maryland
Baltimore, Maryland 21201
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Barbara Ann Karmanos Cancer Institute (Wayne State University)
Detroit, Michigan 48201
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Weill Cornell Medical College - NY Presbyterian Hospital
New York, New York 10021
United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York 10032
United States
Duke University
Durham, North Carolina 27708
United States
Ohio State University
Columbus, Ohio 43210
United States
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island 02903
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
MD Anderson
Houston, Texas 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
Australia
Liverpool Hospital
Liverpool, New South Wales 2170
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
Australia
Barwon Health - Andrew Love Cancer Centre
Geelong, Victoria 3320
Australia