Autoimmune DiseasesJY232NCT07490951
A Clinical Study of the Safety, Tolerability and Preliminary Efficacy of CD19/BCMA-targeted CAR-T Therapy in Refractory Autoimmune Diseases
A study testing CD19/BCMA-targeted CAR-T lentiviral vector drug in people with Autoimmune Diseases, run by Liang Zou at 3 sites in China.
Trial summary
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19/BCMA CAR-T in the treatment of refractory autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- CD19/BCMA-targeted CAR-T lentiviral vector drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesChina
- Study dates
- 22 Mar 2026to 31 Dec 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18~70 years old, male or female; provided written informed consent form (ICF).
- Diagnosis of one of the following diseases:
- Systemic lupus erythematosus (SLE), diagnosed according to the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 criteria, with Antinuclear Antibody (ANA) > 1:80 or positive anti-dsDNA antibody;
- Sjögren's syndrome (SS), diagnosed according to the 2016 ACR/EULAR criteria, with at least positive anti-Sjögren's-syndrome-related antigen A antibody (SSA) antibody;
- Systemic sclerosis (SSc), diagnosed according to the 2013 ACR/EULAR criteria, with ANA > 1:80 or positive anti-Scleroderma (SCL)-70 antibody;
- Dermatomyositis (DM), meeting the 1975 Bohan and Peter criteria for DM or the 2020 European Neuromuscular Centre (ENMC)-DM classification criteria;
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- Antisynthetase syndrome (ASS), meeting the 2010 Conners classification criteria or the 2011 Solomon classification criteria;
- Immune-mediated necrotizing myopathy (IMNM), meeting the 2020 ACR/EULAR classification criteria;
- Rheumatoid arthritis (RA), meeting the ACR/EULAR classification criteria for RA;(8) Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis (AAV), including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), or eosinophilic granulomatosis with polyangiitis (EGPA), diagnosed according to the 2022 ACR/EULAR criteria, with positive ANCA (any of c-ANCA, p-ANCA, anti-Proteinase 3 (PR3), or anti-Myeloperoxidase (MPO) positive).
- Patients who have received treatment with ≥ 2 immunosuppressants for 3 months,or require prednisone ≥ 15 mg daily to maintain stable disease,or are intolerant to standard therapy, or have relative contraindications to standard therapy,and meet the following disease activity criteria:
- For SLE patients: SLEDAI score ≥ 8;
- For SS patients: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 14;
- For SSc patients: modified Rodnan Skin Score (mRSS) score 10-35 (inclusive), and/or complicated with interstitial lung disease (ILD);
- For DM patients: disease duration ≥ 1 year, and meeting all of the following:a. Skin rash Visual Analogue Scale (VAS) score (based on MDAAT) ≥ 3 cm, with at least 3 abnormal Cutaneous, Skeletal Muscle, Systemic (CSM) items;b. Active inflammation demonstrated by muscle biopsy, muscle MRI, or muscle ultrasound;c. Elevation of at least one muscle enzyme [creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST)] to a minimum level of 1.3 × upper limit of normal (ULN);
- For ANCA-AAV patients: Birmingham Vasculitis Activity Score (BVAS) ≥ 15, with positive ANCA.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Organ function meeting the following criteria:
- Hematology: hemoglobin ≥ 60 g/L, platelet count ≥ 20 × 10⁹/L;
- Cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormality on electrocardiogram;
- Renal function: estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73 m²;
- Hepatic function: AST and ALT ≤ 3.0 × ULN, total bilirubin ≤ 2.0 × ULN;
- Eligible for leukapheresis or venous blood collection, with no other contraindications to cell collection.
- Female subjects of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the study until 1 year after infusion.
- The patient or legal guardian agrees to participate in this clinical study, signs the informed consent form, and demonstrates understanding of the purpose and procedures of the study.
Who cannot join
- Prior treatment with CAR-T cell therapy;
- Suffering from severe cardiac, hepatic, pulmonary, hematological, or endocrine diseases, for whom the investigator determines that the risks of participation outweigh the benefits;
- Active infection requiring systemic therapy or uncontrolled infection within 1 week prior to screening;
- Prior hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or acute graft-versus-host disease (GVHD) of Grade 2 or higher within 2 weeks prior to screening;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal reference range;or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal reference range;or positive for human immunodeficiency virus (HIV) antibody;or positive for syphilis;or positive for cytomegalovirus (CMV) DNA;
- Administration of live vaccines within 4 weeks prior to screening;
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- Positive pregnancy test;
- Patients with malignant tumors or other malignant diseases prior to screening, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ after radical surgery;
- Patients who participated in other clinical trials within 3 months prior to screening;
- Any other conditions deemed by the investigator to render the subject ineligible for this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaoya Du contact
China3 sites, 3 recruiting
- Not yet recruiting
Wuhan No.1 Hospital
Wuhan, Hubei
Liang Zou, Doctor, +86 186 0270 1800, zozozou@qq.com
Xiaoya, Du, +86 27 8533 2028
- Recruiting
Wuhan No.1 Hospital
Wuhan, Hubei
Liang Zou Liang Zou, Doctor, +86 186 0270 1800, zozozou@qq.com
- Recruiting
Wuhan No.1 Hospital
Wuhan
Liang Zou Liang Zou, Doctor, +86 186 0270 1800, zozozou@qq.com
About this study
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19/BCMA CAR-T in the treatment of refractory autoimmune diseases.
Read the detailed description
This open-label, single-arm clinical trial aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases.
No lymphodepletion conditioning regimen will be administered in this study. The lentiviral vector drug of CD19/BCMA-targeted CAR-T therapy will be infused directly.
Following infusion, subjects will undergo safety and efficacy assessments for up to 24 months to determine whether disease control is achieved.
- Conditions
- Autoimmune Diseases
- Being tested
- CD19/BCMA-targeted CAR-T lentiviral vector drug
- Keywords
- CD19/BCMA, 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/BCMA-targeted CAR-T lentiviral vector drugDrug
The CD19/BCMA-targeted CAR-T lentiviral vector drug is administered intravenously, and autologous CD19/BCMA-targeted CAR-T cells are produced in the patient's body following infusion.
| Study group | Role | What they receive |
|---|---|---|
| CD19/BCMA CAR-T for the treatment of refractory autoimmune diseases | Experimental | Subjects who meet the inclusion criteria will receive intravenous infusion of the CD19/BCMA-targeted CAR-T lentiviral vector drug.
Following infusion, CD19/BCMA-targeted CAR-T cells will be generated in vivo. Receives: Drug: CD19/BCMA-targeted CAR-T lentiviral vector drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: Day 28, Month 2, Month 3, Month 6, Month 12, Month 18, Month 24
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Measured: Up to 28 days after infusion]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start22 Mar 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liang Zou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liang Zou, Wuhan Integrated Traditional Chinese and Western Medicine Hospital
- Investigators
- Liang Zou, Doctor, Principal investigator, Wuhan No.1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490951
- Sponsor's protocol ID
- JY-CT-26-002
- Acronym
- JY232
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety, Tolerability and Preliminary Efficacy of CD19/BCMA-targeted CAR-T Therapy in Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07490951
- Acronym / sponsor ID
- JY232 / JY-CT-26-002
- Conditions
- Autoimmune Diseases
- Keywords
- CD19/BCMA, CAR-T
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Liang ZouUniversity, hospital or other
- Study start
- 22 Mar 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Mar 2026 (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.
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19/BCMA CAR-T in the treatment of refractory autoimmune diseases.
Detailed description
This open-label, single-arm clinical trial aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases.
No lymphodepletion conditioning regimen will be administered in this study. The lentiviral vector drug of CD19/BCMA-targeted CAR-T therapy will be infused directly.
Following infusion, subjects will undergo safety and efficacy assessments for up to 24 months to determine whether disease control is achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19/BCMA CAR-T for the treatment of refractory autoimmune diseases | Experimental | Drug: CD19/BCMA-targeted CAR-T lentiviral vector drugSubjects who meet the inclusion criteria will receive intravenous infusion of the CD19/BCMA-targeted CAR-T lentiviral vector drug. Following infusion, CD19/BCMA-targeted CAR-T cells will be generated in vivo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age: 18~70 years old, male or female; provided written informed consent form (ICF).
- Diagnosis of one of the following diseases:
- Patients who have received treatment with ≥ 2 immunosuppressants for 3 months,or require prednisone ≥ 15 mg daily to maintain stable disease,or are intolerant to standard therapy, or have relative contraindications to standard therapy,and meet the following disease activity criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Organ function meeting the following criteria:
Key exclusion criteria (10 listed)
- Prior treatment with CAR-T cell therapy;
- Suffering from severe cardiac, hepatic, pulmonary, hematological, or endocrine diseases, for whom the investigator determines that the risks of participation outweigh the benefits;
- Active infection requiring systemic therapy or uncontrolled infection within 1 week prior to screening;
- Prior hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or acute graft-versus-host disease (GVHD) of Grade 2 or higher within 2 weeks prior to screening;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal reference range;or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal reference range;or positive for human immunodeficiency virus (HIV) antibody;or positive for syphilis;or positive for cytomegalovirus (CMV) DNA;
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/BCMA-targeted CAR-T lentiviral vector drugThe CD19/BCMA-targeted CAR-T lentiviral vector drug is administered intravenously, and autologous CD19/BCMA-targeted CAR-T cells are produced in the patient's body following infusion. | Drug | CD19/BCMA CAR-T for the treatment of refractory autoimmune diseases |
Primary outcome
Incidence of adverse events(AE) after infusion
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12, Month 18, Month 24
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximal Tolerated Dose(MTD)
Time frame: Up to 28 days after infusion]
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study 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 27 Jul 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.
Xiaoya Du contact
Liang Zou, Doctor principal investigator
Wuhan No.1 Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD19/BCMA-targeted CAR-T lentiviral vector drug in people with Autoimmune Diseases, run by Liang Zou at 3 sites 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 24 inclusion and 10 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Liang Zou, Doctor (+86 186 0270 1800, zozozou@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events(AE) after infusion (time frame: Day 28, Month 2, Month 3, Month 6, Month 12, Month 18, Month 24). 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 27 Jul 2026.