Clinical trial NCT06880380: The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Official title: The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: HIV Infected Individuals
HIV
Keywords: CAR-T
HIV
Autologous
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Tsinghua University
First posted: 2025-03-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autologous CAR-T cell therapy in HIV-1/AIDS patients


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.

Primary outcomes:
measure: Incidence of adverse reactions
timeFrame: Up to 12 Weeks After CAR T-cell Infusion
Secondary outcomes:
measure: HIV-1 RNA level
timeFrame: Up to 12 Weeks After CAR T-cell Infusion
Other outcomes:
measure: Immunological indicators
timeFrame: Up to 12 Weeks After CAR T-cell Infusion
measure: CAR-T cell kinetics
timeFrame: Up to 12 Weeks After CAR T-cell Infusion
Locations:
Study officials:
References: