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

Phase 1

Not yet recruiting

• Conditions: HIV Infected Individuals; HIV
• Interventions: Biological: HIV-CAR-T

• Registration Number: NCT06880380
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

Autologous CAR-T cell therapy in HIV-1/AIDS patients

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-07
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-03-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T	HIV-CAR-T	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse reactions	Up to 12 Weeks After CAR T-cell Infusion

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA level	Up to 12 Weeks After CAR T-cell Infusion