Autologous CAR-T therapy for a functional cure of HIV-1/AIDS

The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients

This trial will test whether a patient's own CAR-T immune cells can help achieve long-term control of HIV in adults on stable antiviral therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06880380 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-center interventional trial using autologous CAR-T cells engineered to target HIV in people with well-controlled HIV-1 infection. Eligible participants are adults (18–65) on continuous antiretroviral therapy for at least 24 months with sustained viral suppression and adequate CD4 counts; they will undergo leukapheresis, T-cell modification, and infusion of the CAR-T product followed by close safety and laboratory monitoring. The main focus is early safety and tolerability, with secondary measures likely including virologic markers, CD4 counts, and signs of antiviral activity. The study is sponsored by the Institute of Hematology & Blood Diseases Hospital in Tianjin, with collaboration from Tsinghua University.

Who should consider this trial

Good fit: Adults aged 18–65 with confirmed HIV-1 who have been on stable antiretroviral therapy for at least 24 months, have sustained undetectable viral loads (HIV-RNA <50 copies/mL) for the prior year, CD4+ counts above 350/µL, and who can undergo leukapheresis and adhere to follow-up are the intended participants.

Not a fit: People who are pregnant or breastfeeding, have uncontrolled viremia, low CD4 counts, significant comorbidities, or who cannot undergo leukapheresis or comply with follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could enable durable control of HIV without continuous daily antiretroviral therapy, reducing the viral reservoir and the need for lifelong medication.

How similar studies have performed: CAR-T approaches for HIV remain largely experimental: there are encouraging preclinical data and a few early human reports, but no widely replicated evidence of a functional cure to date.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 65 years;
2. 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;
3. CD4+ T-cell count \>350/μl within 30 days prior to enrollment;
4. 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;
5. Willingness to provide true identity information and comply with follow-up requirements;
6. 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:

1. Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
2. Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
3. History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
4. Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
5. Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
6. Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
7. Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
8. 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
9. Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
10. Any other condition deemed inappropriate for participation by the investigator.

Where this trial is running

Tianjin, Tianjin Municipality

• Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020 — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiao Wang, D.Eng

Conditions HIV Infected Individuals; HIV; CAR-T; Autologous