The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
Autologous CAR-T cell therapy in HIV-1/AIDS patients
Eligibility criteria
Qualifiers
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;
Disqualifiers
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).
Trial design
Treatments tested in this trial
- HIV-CAR-T
Treatment groups
3 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Tsinghua University
Collaborator
Source ClinicalTrials.gov