The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called CAR-T cell therapy for people living with HIV-1/AIDS. This therapy involves using a patient's own immune cells, called T cells, which are modified in a lab to better fight the virus that causes HIV. The goal is to see if this treatment can help achieve a functional cure, meaning that the virus is controlled without needing ongoing medication.

To participate in this trial, individuals must be between 18 and 65 years old, have been diagnosed with HIV-1, and have been on stable antiviral treatment for at least two years, with very low levels of the virus in their blood for the past year. Participants will need to be in good overall health, without any serious other infections or health issues. If you join the trial, you can expect to undergo a process that includes modifying your T cells and regular follow-up visits to monitor your health. This trial is not yet recruiting, but it’s an exciting opportunity for those eligible to potentially make significant progress in HIV treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 65 years;
• • 2. 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;
• • 3. CD4+ T-cell count \>350/μl within 30 days prior to enrollment;
• • 4. 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;
• • 5. Willingness to provide true identity information and comply with follow-up requirements;
• • 6. 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 Criteria:
• • 1. Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
• • 2. Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
• • 3. History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
• • 4. Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
• • 5. Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
• • 6. Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
• • 7. Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
• 8. 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
• • 9. Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
• • 10. Any other condition deemed inappropriate for participation by the investigator.