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| Name | Class |
|---|---|
| Affiliated Hospital of Nantong University | OTHER |
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This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT719 Injection treatment group | Experimental | GT719 Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT719 Injection | Biological | GT719 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants experiencing dose limiting toxicity | Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion | 28 days |
| Incidence of treatment-emergent adverse events | Safety assessments are conducted using the NCI-CTCAE version 5.0 standards | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy outcomes for SLE | SLE response index 4 (SR-4) response | 14 days; 1, 2, 3 and 6 Months post GT719 infusion |
| Efficacy outcomes for Systemic Sclerosis | ACR-CRISS score (CRISS score≥0.6 improvment, <0.6 no improvment) |
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Inclusion Criteria:
Specific inclusion criteria:
3. Participants with systemic lupus erythematosus (SLE)
4. Participants with idiopathic inflammatory myopathy (IIM)
5. Participants with systemic sclerosis
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifeng Gu | Contact | 086-13706291941 | guzhifeng@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | China |
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| 14 days; 1, 2, 3, and 6 months post GT719 infusion |
| Efficacy outcomes for Inflammatory Myopathy | Total Improvement Score (TIS) | 14 days; 1, 2, 3, and 6 months post GT719 infusion |