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This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IB-T101 injection treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IB-T101 injection | Biological | IB-T101 injection to treat advanced clear renal cell carcinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater | 3 years |
| AEs | To characterize thesafty profile of autologous TIL injection IB-T101 in patients with advanced fclear renal cell carcinoma as measured by the incidence and severity of adverse events per CTCAE 5.0 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Liu | Contact | 15927168582 | liubo0124@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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