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Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors),3 dose groups.A modified "3+3" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional "3+3" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional "3+3" dose-escalation principle,The second and third dose groups are based on the traditional "3+3" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT201 treatment group | Experimental | GT201 5E9(5×10^9);GT201 1E10(1×10^10);GT201 5E10(5×10^10). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT201 | Drug | Autologous tumor infiltrating lymphocyte injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile Measured By Grade ≥ 3 TREAs | Safety Profile Measured By Grade ≥ 3 TREAs for CTCAE 5.0 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor imaging to determine changes in tumor size | Tumor imaging determines the changes in tumor size at baseline and after treatment.Tumor imaging evaluation according to RECIST v1.1 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Wang, PHD | Contact | +86 18980602258 | wangys@wchscu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The fifth medical center of the General Hospital of the Chinese people's Liberation Army | Recruiting | Beijing | Beijing Municipality | China |
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| Union Hospital Tongji Medical College Huazhong University Of Science And Technology | Recruiting | Wuhan | Hubei | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | China |
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| West China Hospital Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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