Off-the-Shelf CAR t cells take on tough lymphomas and leukemias

NCT ID NCT03666000

Recruiting now Disease control Sponsor: Imugene Limited Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new type of CAR T cell therapy called Azer-cel, which is made from healthy donor cells rather than the patient's own cells. It aims to treat adults with relapsed or refractory non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia, and related blood cancers. Participants receive the donor CAR T cells along with chemotherapy and IL-2 to see if the treatment is safe and can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Azer-cel (azercabtagene zapreleucel), a donor-derived CAR T cell therapy targeting CD19, given with chemotherapy (fludarabine, cyclophosphamide) and IL-2
What this could lead to: If it works, this could provide a readily available, off-the-shelf cell therapy option for patients with hard-to-treat blood cancers who have run out of other treatments.
What could go wrong: This is an early (Phase 1) trial with a small number of participants, so safety and effectiveness are not yet proven. CAR T therapies can cause serious side effects like cytokine release syndrome and neurological problems.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-cell chronic lymphocytic leukemia Burkitt lymphoma diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma marginal zone lymphoma mediastinal malignant lymphoma non-Hodgkin lymphoma primary central nervous system lymphoma Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA CHRONIC LYMPHOCYTIC LEUKEMIA NON-HODGKIN LYMPHOMA SMALL LYMPHOCYTIC LYMPHOMA

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••
Contact

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Locations

Banner MD Anderson Cancer Center
COMPLETED

Gilbert, Arizona, 85234, United States
Barbara Ann Karmanos Cancer Institute (Wayne State University)
COMPLETED

Detroit, Michigan, 48201, United States
Barwon Health - Andrew Love Cancer Centre
RECRUITING

Geelong, Victoria, 3320, Australia
Baylor University Medical Center
RECRUITING

Dallas, Texas, 75246, United States
City of Hope
COMPLETED

Duarte, California, 91010, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Dana-Farber Cancer Institute
COMPLETED

Boston, Massachusetts, 02215, United States
Duke University
COMPLETED

Durham, North Carolina, 27708, United States
H. Lee Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States
Lifespan Cancer Institute at Rhode Island Hospital
RECRUITING

Providence, Rhode Island, 02903, United States
Liverpool Hospital
RECRUITING

Liverpool, New South Wales, 2170, Australia
MD Anderson
COMPLETED

Houston, Texas, 77030, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Northside Hospital Cancer Institute
RECRUITING

Atlanta, Georgia, 30342, United States
Ohio State University
COMPLETED

Columbus, Ohio, 43210, United States
Royal Adelaide Hospital
RECRUITING

Adelaide, South Australia, 5000, Australia
Royal Prince Alfred Hospital
RECRUITING

Camperdown, New South Wales, 2050, Australia
St Vincent's Hospital Melbourne
RECRUITING

Fitzroy, Victoria, 3065, Australia
Tufts Medical Center
RECRUITING

Boston, Massachusetts, 02111, United States
University of Maryland
RECRUITING

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

Minneapolis, Minnesota, 55455, United States
Weill Cornell Medical College - NY Presbyterian Hospital
COMPLETED

New York, New York, 10021, United States
Winship Cancer Institute Emory University
RECRUITING

Atlanta, Georgia, 30322, United States

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