NCT06880380 The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
| NCT ID | NCT06880380 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | HIV Infected Individuals |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 3 participants in total. It began in 2025-09-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06880380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying HIV Infected Individuals. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06880380 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06880380 currently recruiting?
Yes, NCT06880380 is actively recruiting participants. Contact the research team at wangx21@mails.tsinghua.edu.cn for enrollment information.
Where is the NCT06880380 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06880380 clinical trial?
NCT06880380 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 3 participants.
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