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 refractory moderate - to - severe active rheumatoid arthritis.
Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
Expected survival time of at least 3 months.
Subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options.
Meet the requirements for liver and kidney function, as well as cardiopulmonary function.
A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
Subjects with positive results in virus/syphilis tests.
Severe cardiac diseases or unstable systemic diseases.
Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.
Single group
UTAA91 injection
Biological/VaccineAfter signing the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, and safety.
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 UTAA91 injection.
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This trial is not recruiting at the moment. You can still explore other options:
