This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CAR-modified gamma delta T cells
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 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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