Systemic Lupus Erythematosus (SLE)NCT06900764
A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus
A study testing CAR-T cell in people with Systemic Lupus Erythematosus (SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- CAR-T cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 20 Dec 2027
- Phase
- Interventional
- 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
- Male or female, between 18 and 65 years old;
- Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
- Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
- SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
- Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
- Good organ functions;
- Voluntary participates this trial and can comprehend and sign ICF.
Who cannot join
- Had or has active malignancy;
- Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- Combined with other autoimmune disease that needs treatment;
- Pregnant or lactating women;
- Has other factors that deemed not suitable by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Wuhan Union Hospital
Wuhan, Hubei, 430000
Qiubai Li, MD/PhD, +86 (027)85726808, qiubaili@hust.edu.cn
Qiubai Li, MD/PhD
About this study
Official title: A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- CAR-T cell
- Keywords
- SLE, Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cellDrug
CAR-T cell
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment | Experimental | Not described Receives: Drug: CAR-T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: 0~28 day after treatment
Frequency of AEs, SAEs
Measured: 0 day to 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start10 Oct 2025 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900764
- Sponsor's protocol ID
- AID04-01
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT06900764
- Acronym / sponsor ID
- AID04-01
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- SLE, Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 28 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.
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
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 treatment | Experimental | Drug: CAR-T cell |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, between 18 and 65 years old;
- Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
- Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
- SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
- Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
Key exclusion criteria (5 listed)
- Had or has active malignancy;
- Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- Combined with other autoimmune disease that needs treatment;
- Pregnant or lactating women;
- Has other factors that deemed not suitable by investigator.
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 |
|---|---|---|
| CAR-T cellCAR-T cell | Drug | CAR-T treatment |
Primary outcome
Dose Limiting Toxicity
Time frame: 0~28 day after treatment
Frequency of AEs, SAEs
Time frame: 0 day to 24 months after treatment
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 17 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-T cell in people with Systemic Lupus Erythematosus (SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Jul 2025. 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.
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 Qiubai Li, MD/PhD (+86 (027)85726808, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 0~28 day after treatment). The study lists 2 primary outcomes in all. 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 17 Jul 2025.