RecruitingPhase 1NCT06880380

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

3 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

HIV HIV Infected Individuals

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria11

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.

Interventions

BIOLOGICALHIV-CAR-T

Intravenous Infusion of CAR-T Cells

Locations(1)

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

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06880380

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