Relapsed/Refractory Autoimmune DiseasesNCT07193667
CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease
A study testing CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases in people with Relapsed/Refractory Autoimmune Diseases, run by ShenZhen Cell Valley at 1 site in China.
Trial summary
In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed/Refractory Autoimmune Diseases
- What is being tested?
- CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases
- 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
- Oct 2025to 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
- age 18-65 years (including threshold) and gender;
- positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;
- the function of vital organs meets the following requirements:
- Bone marrow function needs to meet the following requirements: a. White blood cell count ≥3×109/L; b. Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g/L;
- Liver function: ALT≤3×ULN (except for elevated ALT caused by inflammatory myopathy); AST≤3×ULN (except for AST elevation caused by inflammatory myopathy); TBIL≤1.5×ULN (except for Gilbert's disease).
- TBIL≤1.5×ULN (except Gilbert's syndrome, total bilirubin≤3.0×ULN);
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- Renal function: creatinine clearance (CrCl) ≥ 30 ml/minute (Cockcroft/Gault formula, except for disease-induced decline in CrCl);
- Coagulation: international normalized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) ≤ 1.5 x ULN.
- Cardiac function: hemodynamic stability;
- female subjects of childbearing potential and male subjects with a partner of childbearing potential are required to use medically approved contraception or be abstinent from sexual intercourse for at least 6 months during and after study treatment; female subjects of childbearing potential must have had a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding;
- Voluntarily participate in this clinical study and sign the informed consent form, good compliance and cooperate with follow-up visits.
- Specific inclusion criteria:
- Relapsed refractory systemic lupus erythematosus.
- meets the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
- have a Disease Activity Score SLEDAI⁃2000 ≥ 6; and have at least one British Isles Lupus Assessment Group Index (BILAG-2004) Category A (severe manifestations) or two Category B (moderate manifestations) organ scores, or both; or have a Disease Activity Score SLEDAI-2000 ≥ 8;
- Definition of relapse-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.
- Relapsing Refractory/Progressive Diffuse Systemic Sclerosis
- meets the 2013 ACR's classification criteria for systemic sclerosis consistent with a diffuse presentation
- is positive for antibodies related to systemic sclerosis;
- diffuse cutaneous sclerosis manifestations or active interstitial lung disease (HRCT suggestive of ground-glass exudates);
- definition of relapsing-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.
- Definition of Progressive: Rapid cutaneous progression (>25% increase in mRSS); or pulmonary progression (10% decrease in FVC, or >5% decrease in FVC with 15% decrease in DLCO).
- Note: It is sufficient if one of Articles 4 and 5 is fulfilled.
- Relapsed refractory/progressive inflammatory myopathy
- meets the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including DM , PM, ASS, and NM);
- is positive for antibodies to myositis;
- in those with muscle involvement, an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measurements (PhGA, PtGA, or Extramuscular Disease Activity Score ≥2; Total HAQ Score ≥0.25); Myosin level 1.5 times the upper limit of the normal range); or MMT-8 ≥142 in the presence of active interstitial lung disease (HRCT suggestive of ground-glass exudates);
- Definition of relapse refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.
- Definition of progressive: the presence of exacerbation of myositis or rapidly progressive interstitial pneumonia.
- Note: It is sufficient if one of Articles 4 and 5 is fulfilled.
- Relapsed Refractory/Progressive Immune Thrombocytopenia
- meets the 2019 American Society of Hematology (ASH) classification criteria for immune thrombocytopenia;
- have bone marrow morphology characterized by increased or normal megakaryocytes with impaired maturation;
- exclude other secondary thrombocytopenia
- Definition of recurrent refractory: a patient who fails to achieve a satisfactory outcome after first-line standard therapy (e.g., glucocorticoids), including a full dose and course of therapy, i.e., platelet counts that cannot be maintained at a safe level (generally considered to be platelet counts > 30 × 10⁹ /L and without overt bleeding symptoms).
- Definition of progressive: a sustained decline in platelet count over the course of the disease, or a progressive worsening of bleeding symptoms, which may be accompanied by signs such as splenomegaly, and a progressively worse response to conventional therapy.
- Note: It is sufficient if one of Articles 4 and 5 is fulfilled.
Who cannot join
- A history of severe drug allergies or sensitivities;
- the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment
- persons with central nervous system disorders caused by ADs or not caused by ADs.
- those with intolerable cardiac function;
- subjects with congenital immunoglobulin defects.
- history of malignant tumors within the last five years.
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- end-stage renal failure;
- subjects with positive Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of the test; subjects with positive antibody to Hepatitis C virus (HCV) and peripheral blood HCV RNA; subjects with positive antibody to Human Immunodeficiency Virus (HIV); and subjects with a positive test for Syphilis;
- mental illness and severe cognitive impairment;
- have participated in other clinical trials within 3 months prior to enrollment;
- immunosuppressants or biologics with a therapeutic effect for the indication within five half-lives prior to enrollment
- women who are pregnant or intend to become pregnant;
- subjects who, in the opinion of the investigator, have other reasons for not being included in the study.
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, 1 recruiting
- Recruiting
No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province
Shenyang, Liaoning, 110001
rui sun, 86+18810616095, sunrui@sz-cell.com
About this study
Official title: CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Diseases
In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.
Read the detailed description
This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows:
- Screening period (D-28 to D-6): After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria.
- Lymphocyte depletion pretreatment (Study D-5 to Study D-3): Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen)
- Rest and Observation (Study D-2 to Study D-1): Follow the study procedures and perform the relevant examinations during the rest and observation period.
- Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-day intervals (Study Day 0) after lymphocyte depletion pretreatment, and post-infusion observations and safety assessments will be performed before, during, and after the cell infusion (day of infusion, days 4, 7, 10, 14, 21, and 28 post-infusion), respectively. Evaluation of efficacy: Subjects will be evaluated for efficacy on the 14th, 28th day, 8th and 12th week after CAR-T cell infusion.
- Follow-up period (W12 to W52 after infusion):The follow-up period is for safety and efficacy evaluation. Safety follow-up: Subjects will be followed for 52 weeks after CAR-T cell infusion. Efficacy Evaluation: Subjects will be evaluated for efficacy at weeks 24, 36, and 52 after CAR-T cell infusion. In addition, the actual frequency of effectiveness evaluations may be increased at the discretion of the investigator.
- Conditions
- Relapsed/Refractory Autoimmune Diseases
- Being tested
- CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases
- Keywords
- 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.
CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseasesDrug
This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows:
- Screening period (D-28 to D-6): After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria.
- Lymphocyte depletion pretreatment (Study D-5 to Study D-3): Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen)
- Rest and Observation (Study D-2 to Study D-1): Follow the study procedures and perform the relevant examinations during the rest and observation period.
- Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-da
| Study group | Role | What they receive |
|---|---|---|
| relapsed/refractory autoimmune diseases | Experimental | Not described Receives: Drug: CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
chimeric status
Detecting the chimerism in recipients' peripheral blood and bone marrow.Chimerism is generally measured in percentages(%)
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory 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
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShenZhen Cell Valley
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Hospital of China Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193667
- Sponsor's protocol ID
- 2024-757-2
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share IPD with The First Affiliated Hospital of China Medical University
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07193667
- Acronym / sponsor ID
- 2024-757-2
- Conditions
- Relapsed/Refractory Autoimmune Diseases
- Keywords
- CAR-T
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- ShenZhen Cell ValleyIndustry (pharma, biotech, devices)
- Collaborators
- First Hospital of China Medical University
- Study start
- Oct 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Sep 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.
In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.
Detailed description
This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows:
- Screening period (D-28 to D-6): After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria.
- Lymphocyte depletion pretreatment (Study D-5 to Study D-3): Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen)
- Rest and Observation (Study D-2 to Study D-1): Follow the study procedures and perform the relevant examinations during the rest and observation period.
- Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-day intervals (Study Day 0) after lymphocyte depletion pretreatment, and post-infusion observations and safety assessments will be performed before, during, and after the cell infusion (day of infusion, days 4, 7, 10, 14, 21, and 28 post-infusion), respectively. Evaluation of efficacy: Subjects will be evaluated for efficacy on the 14th, 28th day, 8th and 12th week after CAR-T cell infusion.
- Follow-up period (W12 to W52 after infusion):The follow-up period is for safety and efficacy evaluation. Safety follow-up: Subjects will be followed for 52 weeks after CAR-T cell infusion. Efficacy Evaluation: Subjects will be evaluated for efficacy at weeks 24, 36, and 52 after CAR-T cell infusion. In addition, the actual frequency of effectiveness evaluations may be increased at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| relapsed/refractory autoimmune diseases | Experimental | Drug: CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- age 18-65 years (including threshold) and gender;
- positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;
- the function of vital organs meets the following requirements:
- TBIL≤1.5×ULN (except Gilbert's syndrome, total bilirubin≤3.0×ULN);
- female subjects of childbearing potential and male subjects with a partner of childbearing potential are required to use medically approved contraception or be abstinent from sexual intercourse for at least 6 months during and after study treatment; female subjects of childbearing potential must have had a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding;
Key exclusion criteria (13 listed)
- A history of severe drug allergies or sensitivities;
- the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment
- persons with central nervous system disorders caused by ADs or not caused by ADs.
- those with intolerable cardiac function;
- subjects with congenital immunoglobulin defects.
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 |
|---|---|---|
| CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseasesThis is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows: 1. Screening period (D-28 to D-6): After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria. 2. Lymphocyte depletion pretreatment (Study D-5 to Study D-3): Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen) 3. Rest and Observation (Study D-2 to Study D-1): Follow the study procedures and perform the relevant examinations during the rest and observation period. 4. Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-da | Drug | relapsed/refractory autoimmune diseases |
Primary outcome
chimeric status
Time frame: 1 year after transplantation
Detecting the chimerism in recipients' peripheral blood and bone marrow.Chimerism is generally measured in percentages(%)
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 26 Sep 2025.
- Individual participant dataSharing planned: Yes. Share IPD with The First Affiliated Hospital of China Medical University
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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 CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases in people with Relapsed/Refractory Autoimmune Diseases, run by ShenZhen Cell Valley 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 37 inclusion and 13 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 26 Sep 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 rui sun (86+18810616095, sunrui@sz-cell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chimeric status (time frame: 1 year after transplantation). 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 26 Sep 2025.