Autoimmune DiseasesNCT07059169
CAR-T Therapy for Refractory Autoimmune Diseases
A study testing JY231 (JY231 injection) in people with Autoimmune Diseases, run by LiangZou at 1 site 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 CAR-T in the treatment of refractory autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- JY231 (JY231 injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2025to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, regardless of gender, signed with informed consent (ICF).
- Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
- Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:
- For SLE patients, SLEDAI ≥ 8 points;
- For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;
- For SSc patients, the modified skin score (mRSS) score ranges from 10 to 35 (including cutoff values) and is associated with interstitial pneumonia (ILD);
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- For DM patients, diagnosed for at least 1 year;
- For ANCA-AAV patients, Birmingham Vasculitis Activity Score(BVAS) score ≥ 15 and ANCA antibodies.
- Eastern Cooperative Oncology Group(ECOG) 0-1 points;
- The evaluation of important organ functions meets the following conditions:
- Blood count: hemoglobin ≥ 60g/L, platelet count ≥ 30 × 109/L;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormalities observed on electrocardiogram;
- Renal function: estimated glomerular filtration rate(eGFR) ≥ 30 mL/min/1.73m2;
- Liver function: Aspartate Aminotransferase(AST) and Alanine Transaminase(ALT) ≤ 3.0 upper limit of normal(ULN), total bilirubin ≤ 2.0 ULN;
- Pulmonary function: diffusion capacity of the lung for carbon monoxide(DLCO) ≥ 40% expected value; forced vital capacity(FVC) ≥ 50% of expected value;
- Having single or intravenous blood collection standards and no other contraindications for cell collection;
- The urine pregnancy test results of subjects of childbearing age are negative, and they agree to take effective contraceptive measures during the trial period, until one year after infusion;
- The patient or their guardian agrees to participate in this clinical trial and signs an informed consent form, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study.
Who cannot join
- Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
- Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
- Active or uncontrollable infections that require systemic treatment within the first week of screening;
- Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;
- Received live vaccine within 4 weeks prior to screening;
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- Pregnancy test positive individuals;
- Patients with malignant tumors and other malignant diseases before screening, in addition to fully treated cervical cancer in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
- Screening patients who have participated in other clinical trials within the first three months;
- Other researchers believe that it is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaoya Du contact
China1 site, 1 recruiting
- Recruiting
Wuhan No.1 Hospital
Wuhan, Hubei
Liang Zou, Doctor, +86 186 0270 1800, zozozou@qq.com
About this study
Official title: An Exploratory Clinical Study of the Safety, Tolerability, and Initial Efficacy of Targeted Cluster of Differentiation 19 (CD19) CAR-T Therapy for Refractory Autoimmune Diseases
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 CAR-T in the treatment of refractory autoimmune diseases.
Read the detailed description
This open-label, single-arm study aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases. The study includes two pretreatment regimens: lymphodepletion and non-lymphodepletion.
Under the lymphodepletion regimen, after enrollment, patients will undergo leukapheresis followed by 3-5 days of fludarabine and cyclophosphamide lymphodepletion therapy. Subsequently, JY231 injection (CAR-T cell therapy) and autologous Peripheral blood mononuclear cell(PBMC) will be concurrently administered via double-lumen catheter intravenous infusion.
The non-lymphodepletion regimen involves direct infusion of JY231 injection without prior lymphodepletion.
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
- JY231 (JY231 injection)
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY231 (JY231 injection)Drug
JY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion.
| Study group | Role | What they receive |
|---|---|---|
| CD19 CAR-T for the treatment of refractory autoimmune diseases | Experimental | CD19 CAR-T for the Treatment of refractory autoimmune diseases subjects who meet the inclusion criteria will receive intravenous JY231 injection. JY231 injection infusion will produce CAR-T cells in the body. Receives: Drug: JY231 (JY231 injection) |
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 posted10 Jul 2025
- Study start4 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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
- LiangZou
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, LiangZou, Shenzhen Genocury Biotech Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059169
- Sponsor's protocol ID
- JY CT-24-003
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2025
- Last updated
- 22 Apr 2026
- Results posted
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of the Safety, Tolerability, and Initial Efficacy of Targeted Cluster of Differentiation 19 (CD19) CAR-T Therapy for Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07059169
- Acronym / sponsor ID
- JY CT-24-003
- Conditions
- Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- LiangZouIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Jul 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.
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 CAR-T in the treatment of refractory autoimmune diseases.
Detailed description
This open-label, single-arm study aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases. The study includes two pretreatment regimens: lymphodepletion and non-lymphodepletion.
Under the lymphodepletion regimen, after enrollment, patients will undergo leukapheresis followed by 3-5 days of fludarabine and cyclophosphamide lymphodepletion therapy. Subsequently, JY231 injection (CAR-T cell therapy) and autologous Peripheral blood mononuclear cell(PBMC) will be concurrently administered via double-lumen catheter intravenous infusion.
The non-lymphodepletion regimen involves direct infusion of JY231 injection without prior lymphodepletion.
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 CAR-T for the treatment of refractory autoimmune diseases | Experimental | Drug: JY231 (JY231 injection)CD19 CAR-T for the Treatment of refractory autoimmune diseases subjects who meet the inclusion criteria will receive intravenous JY231 injection. JY231 injection infusion will produce CAR-T cells in the body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥18 years old, regardless of gender, signed with informed consent (ICF).
- Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
- Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:
- Eastern Cooperative Oncology Group(ECOG) 0-1 points;
- The evaluation of important organ functions meets the following conditions:
Key exclusion criteria (10 listed)
- Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
- Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
- Active or uncontrollable infections that require systemic treatment within the first week of screening;
- Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;
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 |
|---|---|---|
| JY231 (JY231 injection)JY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion. | Drug | CD19 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 22 Apr 2026.
- 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.
Xiaoya Du contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JY231 (JY231 injection) in people with Autoimmune Diseases, run by LiangZou 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 18 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 22 Apr 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?
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 22 Apr 2026.