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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UTAA91 injection | Experimental | Infusion of UTAA91 injection in subjects screened after signing informed consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UTAA91 injection | Biological | Infusion of UTAA91 injection in subjects screened after signing informed consent. |
|
| 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
5. Presence of active or uncontrollable infections requiring systemic treatment.
6. Pregnant or breastfeeding women, as well as female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.
7. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Wu, Doctor | Contact | 15358805676 | njwujian@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Wu, Doctor | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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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 UTAA09 injection. | About 3 months |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| D009220 | Myositis |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D012871 | Skin Diseases |
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