OncoMatch/Clinical Trials/NCT05077527
Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
Is NCT05077527 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Axicabtagene Ciloleucel and Cyclophosphamide for aids-related diffuse large b-cell lymphoma.
Treatment: Axicabtagene Ciloleucel · Cyclophosphamide · Fludarabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
Required: HIV1 positive
Documentation of HIV-1 infection by means of any one of the following: ... (see protocol for details)
Required: HIV1 viral load <50 copies/mL (<50 copies/mL)
HIV viral load below 50 copies/mL by FDA-approved assays within 4 weeks prior to registration
Required: HIV1 CD4 count (CD4 cell count must be obtained; minimum of 6 participants with CD4 <100 cells/uL)
A CD4 cell count must be obtained within 4 weeks before enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent. Twenty participants will be studied with a goal to enroll a minimum of 6 participants with a CD4 <100 cells/uL
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline
Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R/R disease after at least 2 lines of therapy
Must have received: CD20-targeted therapy (rituximab)
Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R/R disease after at least 2 lines of therapy
Cannot have received: alemtuzumab (alemtuzumab)
Treatment with alemtuzumab within 6 months before anticipated leukapheresis
Cannot have received: purine analog (fludarabine, cladribine)
treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis
Cannot have received: CAR-T cell therapy
Prior receipt of CAR T-cell therapy
Lab requirements
Blood counts
Absolute neutrophil count: >= 1,000/mm^3; Platelets: >= 75,000/mm^3 (within 4 weeks before enrollment)
Kidney function
Serum creatinine <= 1.5 x age-adjusted ULN OR calculated creatinine clearance (Cockcroft and Gault) > 30 mL/min/1.73 m^2 (within 4 weeks before enrollment)
Liver function
ALT <= 5 x ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver or if taking atazanavir or indinavir); total bilirubin <= 1.5 x ULN (3.0 x ULN for patients with Gilbert syndrome); if elevated bilirubin is secondary to ART, total bilirubin <= 3.5 mg/dL, direct bilirubin normal, AST and ALT <= 3 x ULN
Cardiac function
LVEF >= 40% as assessed by echocardiogram or MUGA scan performed within 1 month of determination of eligibility
See inclusion criteria for full details on hepatic, renal, hematologic, and cardiac function requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- University of Illinois at Chicago · Chicago, Illinois
- Memorial Sloan Kettering Cancer Center · New York, New York
- The Ohio state University · Columbus, Ohio
- Huntsman Cancer Institute, University of Utah · Salt Lake City, Utah
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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