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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Study sites: 6 to 7v16
  2. Study sites: 5 to 6v15
  3. Study sites: 4 to 5v14
  4. Start date: May 3, 2024 to Feb 13, 2025
    • Site contacts updated at 1 of 4 sites
    v13
  5. Study sites: 3 to 4v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Jan 31, 2026 to Jan 31, 2028
    • Study completion date: Jan 31, 2027 to Jan 31, 2029
    • Site contacts updated at 1 of 3 sites
    v11
  2. Study sites: 2 to 3v10
  3. Re-verified, no change to tracked fieldsv9
  4. Study sites: 1 to 2v8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 20, 2024 to May 3, 2024
    • Site details revised
    v7
  6. Start date: Apr 15, 2024 to Jul 20, 2024
    • Study sites: 0 to 1
    v6
  7. Start date: Jan 15, 2024 to Apr 15, 2024
    • Collaborators: 3 to 2
    v5
  8. Start date: Jul 27, 2023 to Jan 15, 2024
    • Collaborators: 1 to 3
    v4
  9. Start date: Apr 1, 2022 to Jul 27, 2023v3
  10. Start date: Jan 31, 2022 to Apr 1, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05077527
Lead Sponsor AIDS Malignancy Consortium
Collaborators: National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 AIDS-Related Diffuse Large B-cell Lymphoma, AIDS-Related Non-Hodgkin Lymphoma, HIV Infection, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Grade 3b Follicular Lymphoma, Recurrent High Grade B-Cell Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma +7 more
Related terms HIV Infections, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov