Clinical Study of CD19 CAR-T in the Treatment of Refractory Systemic Sclerosis
Trial Parameters
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Brief Summary
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of childhood-onset systemic sclerosis
Eligibility Criteria
Inclusion Criteria: 1. Gender unlimited, age ≥5 years; 2. Meet the classification criteria for Systemic sclerosis (SSc) as defined by the 2013ACR/EULAR standards; 3. any one of the anti-nuclear antibodies or systemic sclerosis specific antibodies positive; 4. Improved Rodnan skin score (mRSS) ≥15 points (total 51 points); 5. Meet the definition of intractable disease: Glucocorticoids (≥0.5mg/kg/d) and cyclophosphamide, as well as one or more of the following immunomodulators (including antimalarial drugs, azathioprine,motecophanate, methotrexate, leflunomide, tachlimus, cyclosporine, and biologics including rituximab, Beliumab, and titacept, etc.), did not show significant remission of the disease for more than 3 months; Or meet the criteria for rapid disease progression , clinical routine treatment is ineffective, and the benefits outweigh the risks as determined by the investigator and the patient's or guardian's full and informed consent can be considered for inclusion. 6. Major org