NCT06880380RecruitingPhase 1
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Institute of Hematology & Blood Diseases Hospital, China1 site in 1 country3 target enrollmentStarted: September 1, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Incidence of adverse reactions
Study Overview
Brief Summary
Autologous CAR-T cell therapy in HIV-1/AIDS patients
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 65 years;
- •Confirmed diagnosis of HIV-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained HIV-RNA levels <50 copies/mL for the 12 months preceding enrollment;
- •CD4+ T-cell count >350/μl within 30 days prior to enrollment;
- •Female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the screening period until the end of the study, participants should have no plans for conception and must voluntarily adopt effective contraceptive measures;
- •Willingness to provide true identity information and comply with follow-up requirements;
- •Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.
Exclusion Criteria
- •Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
- •Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
- •History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
- •Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
- •Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
- •Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
- •Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
- •Abnormal laboratory results within 14 days prior to enrollment meeting any of the following:
- •Hemoglobin <10 g/dL (female) or <11 g/dL (male) Absolute neutrophil count <1 ×10⁹/L Platelet count <100 ×10⁹/L Serum creatinine >110 μmol/L INR >1.5 or PTT >45 seconds ALT or AST >2.5 × upper limit of normal (ULN) Total bilirubin >1.5 × ULN
- •Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
- •Any other condition deemed inappropriate for participation by the investigator.
Arms & Interventions
CAR-T
Experimental
Intervention: HIV-CAR-T (Biological)
Outcomes
Primary Outcomes
Incidence of adverse reactions
Time Frame: Up to 12 Weeks After CAR T-cell Infusion
Secondary Outcomes
- HIV-1 RNA level(Up to 12 Weeks After CAR T-cell Infusion)
Investigators
Study Sites (1)
Loading locations...
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