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).
Following the signing of 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 pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments. Aside from the baseline period, efficacy evaluations will be conducted periodically during the treatment phase after cell reinfusion until the occurrence of one of the following events, with the earliest event taking precedence: disease progression, initiation of new anti - disease treatment, death, intolerable toxicity, the investigator's decision, or the subject's voluntary withdrawal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Infusion of UTAA91 injection in subjects screened after signing informed consent.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
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).
Time frame: About 1 year
Cmax
Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug
Time frame: About 1 year
Tmax
Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection
Time frame: About 1 year
Disease remission rate
The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA09 injection.
Time frame: About 3 months
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