Actively Recruiting
Axicabtagene Ciloleucel for Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma
Led by AIDS Malignancy Consortium · Updated on 2026-04-14
20
Participants Needed
6
Research Sites
52 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
Researchers are evaluating axicabtagene ciloleucel, a CAR-T cell therapy, in patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has relapsed or not responded to treatment. This phase I trial aims to assess the safety and feasibility of this treatment in participants with well-controlled HIV. The study also explores how the therapy affects immune cell profiles and the relationship between immune response and clinical outcomes in this specific lymphoma type. Participants receive conditioning chemotherapy with fludarabine and cyclophosphamide intravenously on days -5, -4, and -3, followed by a single intravenous infusion of axicabtagene ciloleucel on day 0. After treatment, patients are monitored weekly for the first month, monthly for months 2 through 6, and then at 9, 12, 15, 18, and 24 months to observe treatment effects and side effects. During the study, participants undergo assessments including safety monitoring, evaluation of treatment feasibility, and measurements of response rate, event-free survival, and duration of response up to two years. Laboratory tests such as CD4 and CD8 cell counts are also performed. Follow-up visits include clinical evaluations and monitoring for potential side effects, ensuring participant safety throughout the trial.
CONDITIONS
Brief 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
- Diagnosed with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of specified histologies including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or grade 3B follicular lymphoma
- Previously treated with anthracycline and rituximab or other CD20-targeted agent and have relapsed or refractory disease after at least two lines of therapy
- Evaluable disease by PET-positive scan or bone marrow biopsy
- ECOG performance status of 0 or 1 (Karnofsky score 60% or higher)
- Adequate kidney, liver, lung, and heart function as defined by specific laboratory and clinical measures
- Absolute neutrophil count of at least 1,000/mm3 and platelets at least 75,000/mm3
- Adequate vascular access for leukapheresis and treatment administration
- For those with prior CD19-targeted therapy, confirmed CD19-positive lymphoma after prior therapy
- Agreement to use adequate contraception during and for 12 months after treatment if of child-bearing potential
- Confirmed HIV-1 infection with viral load below 50 copies/mL within 4 weeks prior to enrollment
- Willingness to continue antiretroviral therapy during leukapheresis, manufacturing, infusion, and post-infusion
- Participants with hepatitis B or C may be eligible if specific liver function and viral load criteria are met and appropriate antiviral treatment is maintained
You will not qualify if you...
- Candidates likely to benefit from autologous transplantation
- Central nervous system involvement only by malignancy (secondary CNS involvement allowed)
- Prior or concurrent second malignancy that could interfere with safety or efficacy assessment
- Treatment with alemtuzumab within 6 months or fludarabine or cladribine within 3 months before leukapheresis
- Uncontrolled systemic infections
- Presence of acute or chronic graft-versus-host disease
- Recent significant cardiovascular events or severe heart disease
- Clinically relevant central nervous system disorders or pathologies
- Pregnant or nursing women
- Use of high-dose corticosteroids or certain chemotherapies close to leukapheresis or treatment
- Prior receipt of CAR T-cell therapy
- Signs of active CNS involvement unless stable and assessed by MRI and CSF analysis
- Use of immunosuppressive therapies within 4 weeks before leukapheresis and treatment
- Allergic reactions to components similar to axicabtagene ciloleucel
- Uncontrolled intercurrent illnesses including active infections or psychiatric illness
- Recent opportunistic infections except oropharyngeal candidiasis
- Not recovered from prior therapy toxicities except minor or non-clinically significant adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 days
Participants receive conditioning chemotherapy with fludarabine and cyclophosphamide intravenously over 3 days, followed by a single infusion of axicabtagene ciloleucel.
4 visits (in-person) including days -5, -4, -3, and day 0
Duration - Up to 24 months
After treatment, participants are monitored for safety and efficacy with weekly visits during the first month, monthly visits from months 2 to 6, and additional visits at months 9, 12, 15, 18, and 24.
Weekly visits for 1 month, monthly visits for 5 months, plus 5 visits between months 9 and 24
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here