CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease

Recruiting now · Not applicable

Conditions studied: Relapsed/Refractory Autoimmune Diseases

In brief

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.

Key facts

Study ID: NCT07193667
Run by: ShenZhen Cell Valley
People needed: 3
Starts: 2025-10-01
Expected to finish: 2027-12-01
Last updated by the study team: 2025-09-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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);
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);

You may not qualify if…

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.
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.

Where it is running

No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

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