Actively Recruiting
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-05
3
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
Tsinghua University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Autologous CAR-T cell therapy in HIV-1/AIDS patients
CONDITIONS
Official Title
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Confirmed HIV-1 infection with regular antiviral therapy for at least 24 months
- Sustained HIV-RNA levels below 50 copies/mL for the 12 months before enrollment
- CD4+ T-cell count above 350/µL within 30 days before enrollment
- Female participants of childbearing potential must have a negative urine pregnancy test and use effective contraception during the study
- Willingness to provide true identity and comply with follow-up
- Ability to understand study objectives, procedures, risks, and provide informed consent
You will not qualify if you...
- Women who are pregnant, breastfeeding, or unwilling/unable to use effective contraception
- Coinfections with HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis
- History of AIDS-related opportunistic infections or malignancies within the past year
- Autoimmune diseases requiring systemic immunosuppressive therapy within the past 2 years
- Severe non-AIDS-related diseases affecting major organs or malignancies
- Central nervous system disorders such as epilepsy, stroke, dementia, or autoimmune CNS diseases
- History or suspicion of alcohol abuse, drug addiction, or psychiatric disorders
- Abnormal lab results within 14 days before enrollment, including low hemoglobin, low neutrophils, low platelets, high creatinine, abnormal clotting times, elevated liver enzymes, or bilirubin
- Current participation in conflicting clinical trials
- Any other condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
X
Xiao Wang, D.Eng
CONTACT
X
Xuanling Shi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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