Actively Recruiting
Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
Led by AIDS Malignancy Consortium · Updated on 2026-04-14
20
Participants Needed
6
Research Sites
206 weeks
Total Duration
On this page
Sponsors
A
AIDS Malignancy Consortium
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Able to understand and willing to sign informed consent
- Have relapsed or refractory aggressive B-cell non-Hodgkin lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or grade 3B follicular lymphoma
- Previously treated with an anthracycline and rituximab or other CD20-targeted agent and have relapsed or refractory disease after at least two lines of therapy
- At least 2 weeks or 5 half-lives since any prior systemic cancer therapy before consent
- Have evaluable disease by PET-positive disease or bone marrow involvement
- ECOG performance status of 0 or 1 (Karnofsky score ≥ 60%)
- Serum creatinine ≤ 1.5 times age-adjusted upper limit of normal or creatinine clearance > 30 mL/min/1.73 m² within 4 weeks before enrollment
- ALT ≤ 5 times upper limit of normal and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for certain conditions) within 4 weeks before enrollment
- Adequate pulmonary function with oxygen saturation ≥ 92% on room air within 4 weeks before enrollment
- Adequate cardiac function with LVEF ≥ 40% within 1 month before eligibility
- Absolute neutrophil count ≥ 1,000/mm³ and platelets ≥ 75,000/mm³ within 4 weeks before enrollment
- Total bilirubin ≤ 1.5 times institutional upper limit of normal (3.0 times for Gilbert syndrome) or ≤ 3.5 mg/dL if elevated due to antiretroviral therapy
- Adequate vascular access for leukapheresis and cellular product administration
- Confirmed CD19-positive lymphoma if previously treated with CD19-targeted therapy
- Agree to use effective contraception during the study and for 12 months after last dose if of childbearing potential
- Documented HIV-1 infection with viral load below 50 copies/mL and CD4 cell count obtained within 4 weeks before enrollment
- Participants with hepatitis B or C may be enrolled if stable and on antiviral therapy as required
- Willing to continue antiretroviral therapy during leukapheresis, manufacturing, infusion, and post-infusion
You will not qualify if you...
- Candidates likely to benefit from autologous transplantation
- CNS-only involvement by malignancy
- Second prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Treatment with alemtuzumab within 6 months or fludarabine/cladribine within 3 months before leukapheresis
- Uncontrolled systemic infections despite treatment
- Presence of acute or chronic graft-versus-host disease
- Significant cardiovascular conditions within past 6 months
- History or presence of serious CNS pathology such as epilepsy, stroke, severe brain injuries, or psychosis
- Pregnant or nursing women
- Use of therapeutic corticosteroids above specified doses within set timeframes before treatment
- Recent chemotherapy or radiation within specified windows before leukapheresis
- Prior receipt of CAR T-cell therapy
- Active CNS involvement symptoms, except stable previously treated cases
- Use of immunosuppressive therapies or donor lymphocyte infusions within specified timeframes
- Allergic reactions to similar compounds
- Uncontrolled intercurrent illness or psychiatric illness limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
The Ohio state University
Columbus, Ohio, United States, 43210
Actively Recruiting
5
University of Pennsylvania / Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
A
Ariela Noy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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