An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK in the Treatment of Relapsed and Refractory IgG4-related Disease

Inclusion criteria

• ✓. Subjects must be able to understand and provide informed consent and be willing to comply with study procedures and follow-up.
• ✓. The age at the time of signing the informed consent must be at least 18 years old and no more than 70 years old.
• ✓. Meet the 2020 Japanese criteria or ACR/EULAR IgG4-RD classification criteria.
• ✓. Subjects with relapsed/refractory active IgG4-RD at screening on an IgG4-RD RI ≥4, simultaneously meeting the following definitions of relapse or refractory disease:
• ✓. Definitions of relapse: subjects with IgG4-RD achieved remission after treatment but was active again before screening, and were classified as a high-risk group for recurrence assessed by assessment committee ;
• ✓. Definitions of before screening: subjects had used glucocorticoids or glucocorticoids combined with at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs) (including cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, elorimod, thalidomide, etc.), or at least one approved biologic agent (bDMARDs) (including rituximab, abatacept, etanercept, belimumab, etc.), or targeted synthetic (ts) DMARDs (including tofacitinib, upadacitinib, baricitinib, abrocitinib, deucravacitinib, etc.) for treatment, with a total treatment duration of ≥3 months, yet still in an active disease state, ineffective, intolerant, or experiencing relapse during glucocorticoid tapering.
• ✓. No history of severe allergic reaction.
• ✓. Female participants of childbearing age must have a negative pregnancy test upon enrollment in the study; indeterminate results will not be accepted.

Exclusion criteria