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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Not yet enrolling; Phase 1

Conditions: HIV; HIV Infected Individuals

Treatments: Biological: HIV-CAR-T

Study type: Interventional

Funder types: Other

Identifiers

NCT06880380

IIT2024087

Details and patient eligibility

About

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

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

CAR-T

Experimental group

Treatment:

Biological: HIV-CAR-T