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

NCT ID: NCT06880380

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2026-07-01

Brief Summary

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

Conditions

HIV Infected Individuals; HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T

Group Type: EXPERIMENTAL

HIV-CAR-T

Intervention Type: BIOLOGICAL

Intravenous Infusion of CAR-T Cells

Interventions

HIV-CAR-T

Intravenous Infusion of CAR-T Cells

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tsinghua University

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiao Wang, D.Eng

Role: CONTACT

wangx21@mails.tsinghua.edu.cn

+86 22 2746 8129

Xuanling Shi, MD

Role: CONTACT

shixuanlingsk@mail.tsinghua.edu.cn

Other Identifiers

IIT2024087

Identifier Type: -

Identifier Source: org_study_id