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

NCT06880380 | Recruiting Phase 1

• 1 other identifier: IIT2024087
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV; HIV Infected Individuals

Keywords

CAR-T; HIV; Autologous

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

  Up to 12 Weeks After CAR T-cell Infusion

Secondary Outcomes (1)

• HIV-1 RNA level

  Up to 12 Weeks After CAR T-cell Infusion

Other Outcomes (2)

• 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

• CAR-T cell kinetics

  Up to 12 Weeks After CAR T-cell Infusion

Study Arms (1)

CAR-T

EXPERIMENTAL

Biological: HIV-CAR-T

Interventions

HIV-CAR-T BIOLOGICAL

Intravenous Infusion of CAR-T Cells

CAR-T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years;
• 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;
• CD4+ T-cell count \>350/μl within 30 days prior to enrollment;
• 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;
• Willingness to provide true identity information and comply with follow-up requirements;
• Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.

You may not qualify if:

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

Sponsors & Collaborators

• Tsinghua University: collaborator
• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Central Study Contacts

Xiao Wang, D.Eng

CONTACT

+86 22 2746 8129; wangx21@mails.tsinghua.edu.cn

Xuanling Shi, MD

CONTACT

shixuanlingsk@mail.tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: September 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)