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.
Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
Expected survival time of ≥3 months.
Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.
Meets 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.
Positive results in virology/syphilis tests.
Severe cardiac diseases or unstable systemic diseases.
Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.
Single group
UTAA91 injection
Biological/VaccineCAR-modified gamma delta T cells
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:
