RecruitingPhase 1NCT03666000

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)

A 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)

Sponsor

Imugene Limited

Enrollment

135 participants

Start Date

Mar 11, 2019

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma Small Lymphocytic Lymphoma B-cell Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new CAR T-cell therapy called Azer-cel (PBCAR0191) — a treatment where immune cells are genetically engineered from a donor (not the patient) to attack a protein called CD19 found on certain blood cancer cells — in patients with blood cancers that have returned or stopped responding to treatment. **You may be eligible if...** - You have relapsed or treatment-resistant CD19-positive B-cell acute lymphoblastic leukemia (B-ALL), or - You have aggressive CD19-positive B-cell non-Hodgkin lymphoma (such as DLBCL, follicular lymphoma, or mantle cell lymphoma) that has come back after prior treatment including a CD19-targeting therapy - You have tried standard treatments but your cancer has not responded or has returned - You are in adequate overall health **You may NOT be eligible if...** - You have active brain involvement by your cancer - You have had certain prior gene therapies or allogeneic cell therapies - You have serious infections, heart problems, or organ dysfunction - You are pregnant or breastfeeding - You have an autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAzer-cel

Infusion of Allogeneic Anti-CD19 CAR T cells

DRUGFludarabine

Specified dose on specified days

DRUGCyclophosphamide

Specified dose on specified days

DRUGIL-2

Specified dose on specified days

Locations(23)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute Emory University

Atlanta, Georgia, United States

Northside Hospital Cancer Institute

Atlanta, Georgia, United States

University of Maryland

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute (Wayne State University)

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Weill Cornell Medical College - NY Presbyterian Hospital

New York, New York, United States

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States

Duke University

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Lifespan Cancer Institute at Rhode Island Hospital

Providence, Rhode Island, United States

Baylor University Medical Center

Dallas, Texas, United States

MD Anderson

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Barwon Health - Andrew Love Cancer Centre

Geelong, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03666000

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