HIV Infected IndividualsPhase 1HIV-CAR-TNCT06880380
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
A Phase 1 study testing HIV-CAR-T in people with HIV Infected Individuals and HIV, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Autologous CAR-T cell therapy in HIV-1/AIDS patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infected Individuals, HIV
- What is being tested?
- HIV-CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years;
- 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;
- CD4+ T-cell count >350/μl within 30 days prior to enrollment;
- 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;
- Willingness to provide true identity information and comply with follow-up requirements;
- Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.
Who cannot join
- Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
- Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
- History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
- Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
- Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
- Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
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- Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
- 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
- Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
- Any other condition deemed inappropriate for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xuanling Shi, MD contact
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020
Tianjin, Tianjin Municipality, 300020
Ying Wang, 86-22-23608095, wangying1@ihcams.ac.cn
About this study
Autologous CAR-T cell therapy in HIV-1/AIDS patients
- Conditions
- HIV Infected Individuals, HIV
- Being tested
- HIV-CAR-T
- Keywords
- CAR-T, HIV, Autologous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-CAR-TBiological
Intravenous Infusion of CAR-T Cells
| Study group | Role | What they receive |
|---|---|---|
| CAR-T | Experimental | Not described Receives: Biological: HIV-CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Measured: Up to 12 Weeks After CAR T-cell Infusion
Secondary outcomes (1)
HIV-1 RNA level
Measured: Up to 12 Weeks After CAR T-cell Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Sep 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infected IndividualsStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880380
- Sponsor's protocol ID
- IIT2024087
- Acronym
- HIV-CAR-T
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share the results through published medical journal articles and at conference presentation after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
- ClinicalTrials.gov ID
- NCT06880380
- Acronym / sponsor ID
- HIV-CAR-T / IIT2024087
- Conditions
- HIV Infected Individuals, HIV
- Keywords
- CAR-T, HIV, Autologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autologous CAR-T cell therapy in HIV-1/AIDS patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T | Experimental | Biological: HIV-CAR-T |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years;
- 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;
- CD4+ T-cell count >350/μl within 30 days prior to enrollment;
- 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;
- Willingness to provide true identity information and comply with follow-up requirements;
Key exclusion criteria (11 listed)
- Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
- Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
- History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
- Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
- Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV-CAR-TIntravenous Infusion of CAR-T Cells | Biological | CAR-T |
Primary outcome
Incidence of adverse reactions
Time frame: Up to 12 Weeks After CAR T-cell Infusion
1 secondary outcome
HIV-1 RNA level
Time frame: Up to 12 Weeks After CAR T-cell Infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. We will share the results through published medical journal articles and at conference presentation after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xuanling Shi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIV-CAR-T in people with HIV Infected Individuals and HIV, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Wang, D.Eng (+86 22 2746 8129, wangx21@mails.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: Up to 12 Weeks After CAR T-cell Infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.