Tests CAR-T cell therapy in adults living with HIV-1
Tests patient-derived CAR-T cells in adults aged 18 to 65 with HIV-1.
Plain-language title generated from the registry record
Registry title: The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06880380, who can take part
Where in China
- Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020Tianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06880380
- Record updated
- 5 March 2026
- Original description
Autologous CAR-T cell therapy in HIV-1/AIDS patientsRead full original descriptionShow less
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Autologous CAR-T cell therapy in HIV-1/AIDS patients
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: 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; Any other condition deemed inappropriate for participation by the investigator; 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; Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception; Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.