Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT06880380

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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