Autologous CAR-T therapy for a functional cure of HIV-1/AIDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single-center interventional trial using autologous CAR-T cells engineered to target HIV in people with well-controlled HIV-1 infection. Eligible participants are adults (18–65) on continuous antiretroviral therapy for at least 24 months with sustained viral suppression and adequate CD4 counts; they will undergo leukapheresis, T-cell modification, and infusion of the CAR-T product followed by close safety and laboratory monitoring. The main focus is early safety and tolerability, with secondary measures likely including virologic markers, CD4 counts, and signs of antiviral activity. The study is sponsored by the Institute of Hematology & Blood Diseases Hospital in Tianjin, with collaboration from Tsinghua University.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xiao Wang, D.Eng
• Email: wangx21@mails.tsinghua.edu.cn
• Phone: +86 22 2746 8129

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.