This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with relapsed/refractory autoimmune inflammatory diseases (AID).
Age ≥ 18 years (including the cut - off value), with no restrictions on gender.
Expected survival time ≥ 3 months.
Subjects with relapsed/refractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, Sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
Liver and kidney functions and cardiopulmonary functions meet the requirements.
Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.
Subjects with positive virus and/or syphilis tests.
Presence of severe heart disease or unstable systemic diseases.
Single group
UTAA91 injection
Biological/VaccineInfusion of UTAA91 injection in subjects screened after signing informed consent.
Adverse events
The types, frequency, and severity of adverse events (AEs) and laboratory abnormalities (according to the Common Terminology Criteria for Adverse Events, NCI CTCAE 5.0).
Cmax
Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug
Tmax
Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection
Disease remission rate
The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA09 injection.
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This trial is not recruiting at the moment. You can still explore other options:
