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NCT05077527 · ClinicalTrials.gov registry record · Phase 1
Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
A Phase 1 study of HIV Infection and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by AIDS Malignancy Consortium.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 5
- Study locations
NCT05077527: Recruiting Phase 1 study of HIV Infection and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by AIDS Malignancy Consortium.
NCT05077527 is a Phase 1 study of HIV Infection and Recurrent Diffuse Large B-Cell Lymphoma that is actively recruiting participants, run by AIDS Malignancy Consortium. The registered enrollment target is 20 participants, below the 243-participant average among 73 other HIV Infection trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05077527, a Phase 1 study of HIV Infection and Recurrent Diffuse Large B-Cell Lymphoma, is actively recruiting participants, sponsored by AIDS Malignancy Consortium.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Safety defined as blood count recovery of neutrophils and platelets to grade 2 or less within 6 weeks of CAR-T cell administration; incidence of infections; and cytokine release syndrome as defined by the 2019 American Society for Transplantation and Cellular Therapy harmonized system. The incidence of toxicity will be summarized using frequency and percentage and presented by overall and for each CD4 cohort.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Axicabtagene Ciloleucel
Study Locations (5)
California
- City of Hope Comprehensive Cancer Center - Duarte
Illinois
- University of Illinois at Chicago - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- The Ohio state University - Columbus
Utah
- Huntsman Cancer Institute, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-02-13 |
| Est. Completion | 2029-01-31 |
| Phase | Phase 1 |
What NCT05077527 shows while recruiting
NCT05077527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 243-participant average among 73 other HIV Infection trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with HIV Infection appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT05077527 lists 5 locations in 5 states (California, Illinois, New York).
Frequently Asked Questions
What is clinical trial NCT05077527 about?
NCT05077527 is a clinical study titled "Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma". 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)....
What is the current status of trial NCT05077527?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-02-13. Estimated completion is 2029-01-31.
What conditions does trial NCT05077527 study?
This clinical trial studies the following conditions: HIV Infection, Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Grade 3b Follicular Lymphoma.
What interventions are being tested in trial NCT05077527?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT05077527?
This trial is sponsored by AIDS Malignancy Consortium, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05077527 being conducted?
This trial has 5 study locations across California, Illinois, New York, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05077527's enrollment target sits among peer trials
20 60th of 73 higher than 11 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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