A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19/BCMA CAR NK cells (KN5601) in patients with IgG4 related diseases.
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.
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 ;
Presence of a condition other than IgG4-RD that (e.g., asthma) is likely to require systemic Glucocorticoids (GC) for disease control during the period of the trial.
Malignancy within 5 years (except successfully treated in situ cancer, resected squamous cell or basal cell carcinoma of the skin.).
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal (ULN).
Total bilirubin > two times the ULN unless caused by Gilbert's disease. Gilbert's disease with total bilirubin > three times ULN.
Single group
CD19/BCMA CAR NK
Biological/VaccinePatients will receive Fludarabine and Cyclophosphamide on day -5, -4, and -3. Multiple doses of CD19/BCMA CAR NK cells will infused using the dose-escalation strategy.
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases
The percentage of disease remission (Remission is defined as IgG4-RD RI=0 after treatment and without the use of hormones
To characterize the safety of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases
Percentage of disease remission of IgG4-RD RI score compared with baseline
To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases
Percentage of complete response, partial response, and no change (NC)
To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases
Disease recurrence rate
To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases
Physician Global Assessment (PhGA) compared with baseline
To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related disease
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This trial is not recruiting at the moment. You can still explore other options:
