RecruitingPhase 1NCT05077527

Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma

Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma


Sponsor

AIDS Malignancy Consortium

Enrollment

20 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying CAR-T cell therapy (a treatment where your own immune cells are engineered to attack cancer) for people with HIV who also have aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to prior treatments. **You may be eligible if...** - You are 18 or older and HIV-positive - You have relapsed or refractory aggressive B-cell lymphoma (DLBCL, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or follicular lymphoma grade 3B) - You have received at least 2 prior lines of therapy including an anthracycline and rituximab - You have evaluable disease on PET scan or bone marrow biopsy - Your kidney, liver, lung, and heart function are adequate **You may NOT be eligible if...** - You have active brain involvement from lymphoma - You have uncontrolled infections or active autoimmune disease requiring treatment - You are pregnant or breastfeeding - Your general health is too poor (ECOG > 1) 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

BIOLOGICALAxicabtagene Ciloleucel

Given IV

DRUGCyclophosphamide

Given IV

DRUGFludarabine

Given IV


Locations(6)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio state University

Columbus, Ohio, United States

University of Pennsylvania / Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT05077527


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