Autoimmune DiseasesNCT06661811
A Study of CAR-T Cells Targeting Autoimmune Diseases
A study testing CAR-T in people with Autoimmune Diseases, run by Beijing Boren Hospital 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 patients with autoimmune disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 56 years old;
- Diagnosed with Autoimmune Diseases；
- 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.
About this study
Official title: A Study of CAR-T Cells Targeting B Cell Related Autoimmune Diseases
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.
Read the detailed description
Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs.
Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.
CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.
- Conditions
- Autoimmune Diseases
- Being tested
- CAR-T
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TDrug
CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment | Experimental | Not described Receives: Drug: CAR-T |
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 Oct 2024
- Study start15 Nov 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Why it stopped: No participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yajing Zhang, MD/PhD, Principal investigator, Beijing Gaobo Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661811
- Sponsor's protocol ID
- AID02
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of CAR-T Cells Targeting B Cell Related Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06661811
- Acronym / sponsor ID
- AID02
- Conditions
- Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 28 Oct 2024 (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 patients with autoimmune disease.
Detailed description
Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs.
Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.
CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.
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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, between 18 and 56 years old;
- Diagnosed with Autoimmune Diseases；
- Good organ functions;
- Voluntary participates this trial and can comprehend and sign ICF.
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-TCAR-T cells | 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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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. This study is not recruiting at the moment.
Yajing Zhang, MD/PhD principal investigator
Beijing Gaobo Boren Hospital
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 in people with Autoimmune Diseases, run by Beijing Boren Hospital 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 4 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: withdrawn, as of the sponsor's last update on 15 Oct 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 15 Oct 2026.