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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UTAA91 injection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UTAA91 injection | Biological | CAR-modified gamma delta T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | About 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug | About 1 year |
| Tmax | Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiubai Li, MD | Contact | +86-13995671635 | qiubaili@hust.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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After signing the informed consent form, eligible subjects will be infused with UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, safety, etc.
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| 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. | About 3 months |