CAR-T Therapy for Refractory Autoimmune Diseases

Launched by LIANGZOU · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called CAR-T therapy for people with autoimmune diseases that have not improved with standard treatments. Autoimmune diseases happen when the body’s immune system mistakenly attacks healthy tissues. This study is focused on patients with certain tough-to-treat autoimmune conditions, like lupus, Sjogren’s syndrome, scleroderma, dermatomyositis, and a type of blood vessel inflammation called ANCA-associated vasculitis. The main goal is to see if this CAR-T therapy is safe and whether it shows any early signs of helping these patients.

To join the study, participants need to be adults diagnosed with one of these specific diseases and have tried at least two different treatments without success or need higher doses of steroids to keep their condition stable. They also must have active disease based on specific tests, and meet certain health requirements to ensure their organs are working well enough. The trial is not yet recruiting, but those who take part will receive the CAR-T treatment and be closely monitored to understand its effects and any side effects. Patients who have had CAR-T therapy before, serious infections, certain other medical conditions, or who are pregnant will not be eligible. If you or a loved one fits this description and is interested, it’s important to discuss this option with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old, regardless of gender, signed with informed consent (ICF).
• • 2. 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).
• 3. 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:
• • 1. For SLE patients, SLEDAI ≥ 8 points;
• • 2. For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;
• • 3. For SSc patients, the modified skin score (mRSS) score ranges from 10 to 35 (including cutoff values) and is associated with interstitial pneumonia (ILD);
• • 4. For DM patients, diagnosed for at least 1 year;
• • 5. For ANCA-AAV patients, Birmingham Vasculitis Activity Score(BVAS) score ≥ 15 and ANCA antibodies.
• • 4. Eastern Cooperative Oncology Group(ECOG) 0-1 points;
• 5. The evaluation of important organ functions meets the following conditions:
• • 1. Blood count: hemoglobin ≥ 60g/L, platelet count ≥ 30 × 109/L;
• • 2. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormalities observed on electrocardiogram;
• • 3. Renal function: estimated glomerular filtration rate(eGFR) ≥ 30 mL/min/1.73m2;
• • 4. Liver function: Aspartate Aminotransferase(AST) and Alanine Transaminase(ALT) ≤ 3.0 upper limit of normal(ULN), total bilirubin ≤ 2.0 ULN;
• • 5. Pulmonary function: diffusion capacity of the lung for carbon monoxide(DLCO) ≥ 40% expected value; forced vital capacity(FVC) ≥ 50% of expected value;
• • 6. Having single or intravenous blood collection standards and no other contraindications for cell collection;
• • 6. 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;
• • 7. 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.
• Exclusion Criteria:
• • 1. Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
• • 2. 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;
• • 3. Active or uncontrollable infections that require systemic treatment within the first week of screening;
• • 4. 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;
• • 5. 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;
• • 6. Received live vaccine within 4 weeks prior to screening;
• • 7. Pregnancy test positive individuals;
• • 8. 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;
• • 9. Screening patients who have participated in other clinical trials within the first three months;
• • 10. Other researchers believe that it is not suitable to participate in this study.