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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HIV-CAR-T
Biological/VaccineIntravenous Infusion of CAR-T Cells
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: CAR-TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse reactions
Time frame
Up to 12 Weeks After CAR T-cell InfusionSecondary outcomes
1
HIV-1 RNA level
Time frame
Up to 12 Weeks After CAR T-cell InfusionOther outcomes
1
Immunological indicators
Time frame
Up to 12 Weeks After CAR T-cell Infusion Description CAR transgene presence will be assessed in peripheral blood mononuclear cells using quantitative PCR at predefined time points after infusion. Quantitative results, when available, may be used to des2
CAR-T cell kinetics
Time frame
Up to 12 Weeks After CAR T-cell InfusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Tsinghua University
Collaborator
Source ClinicalTrials.gov