Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients With r/r NHL and r/r B-cell ALL

Description

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 and r/r B-cell NHL.

Conditions

Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia

Study Overview

Study Details

Study overview

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 and r/r B-cell NHL.

Phase 1/1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 (Azercabtagene Zapreleucel or "Azer-cel") in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients With r/r NHL and r/r B-cell ALL

Condition
Non-Hodgkin Lymphoma
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Duarte

City of Hope, Duarte, California, United States, 91010

Tampa

H. Lee Moffitt Cancer Center, Tampa, Florida, United States, 33612

Atlanta

Winship Cancer Institute Emory University, Atlanta, Georgia, United States, 30322

Atlanta

Northside Hospital Cancer Institute, Atlanta, Georgia, United States, 30342

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Boston

Tufts Medical Center, Boston, Massachusetts, United States, 02111

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Barbara Ann Karmanos Cancer Institute (Wayne State University), Detroit, Michigan, United States, 48201

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Imugene Limited,

    John Byon, MD, PhD, STUDY_CHAIR, Imugene Limited

    Study Record Dates

    2027-06