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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UTAA91 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UTAA91 injection | Biological | After 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. |
| 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 | +8613995671635 | 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 | Recruiting | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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UTAA91 injection
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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 UTAA91 injection. | About 3 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |