Status:
NOT_YET_RECRUITING
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Tsinghua University
Conditions:
HIV Infected Individuals
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Autologous CAR-T cell therapy in HIV-1/AIDS patients
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06880380
Start Date
March 7 2025
End Date
July 1 2026
Last Update
March 17 2025
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