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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 living with HIV-1 who have long taken antiviral therapy and have a very low virus level. It tests CAR-T cells made from the person's own cells.
- Age
- 18 to 65 years
- Sex
- All sexes
- Disease stage
- Confirmed HIV-1 infection with HIV-RNA below 50 copies/mL for the 12 months before enrollment; CD4+ T-cell count above 350/μl within 30 days before enrollment.
- Earlier treatment
- Regular antiviral therapy for at least 24 months before enrollment.
- Biomarker or test result
- HIV-RNA below 50 copies/mL for 12 months; CD4+ T-cell count above 350/μl.
Main reasons for not taking part
- Pregnant or breastfeeding women, or women who can have children and cannot use effective contraception
- Infection with other viruses or infections such as HIV-2, hepatitis, EBV, CMV or syphilis
- AIDS-related opportunistic infection or cancer in the past year
- Autoimmune disease needing treatment that lowers the immune system in the past 2 years
- Central nervous system disorders, alcohol or drug abuse, or abnormal blood, kidney or liver tests
Read by machine on 12 November 2026.
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, ChinaContact: Ying WangTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.