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

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

Study Overview

• Status: Recruiting
• Conditions: HIV; HIV Infected Individuals
• Intervention / Treatment: Biological: HIV-CAR-T

• Study Type: Interventional
• Enrollment (Estimated): 3
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xuanling Shi, MD; Email: shixuanlingsk@mail.tsinghua.edu.cn
• Study Contact Backup: Name: Xiao Wang, D.Eng; Phone Number: +86 22 2746 8129; Email: wangx21@mails.tsinghua.edu.cn

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Recruiting
      • Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020
      • Contact: Ying Wang; Phone Number: 86-22-23608095; Email: wangying1@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAR-T	Biological: HIV-CAR-T; Intravenous Infusion of CAR-T Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse reactions	Up to 12 Weeks After CAR T-cell Infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
HIV-1 RNA level	Up to 12 Weeks After CAR T-cell Infusion

Other Outcome Measures

Outcome Measure	Time Frame
CAR-T cell kinetics	Up to 12 Weeks After CAR T-cell Infusion
Immunological indicators	Up to 12 Weeks After CAR T-cell Infusion Description CAR transgene presence will be assessed in peripheral blood mononuclear cells using quantitative PCR at predefined time points after infusion. Quantitative results, when available, may be used to des

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Collaborators: Tsinghua University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV; CAR-T; Autologous
• Other Study ID Numbers: IIT2024087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will share the results through published medical journal articles and at conference presentation after completion of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No