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This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period.
The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT101 treatment group | Other | Autologous tumor infiltrating lymphocyte injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT101 | Biological | Autologous tumor infiltrating lymphocyte injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile Measured by Grade ≥3 TEAEs | To characterize the safety profile of autologous TIL injection(GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs) | 3 years |
| Objective response rate | To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator | 3 years |
| Overall survival | To evaluate efficacy parameters such Overall Survival (OS) | 3 years |
| Progression-free survival | To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator | 3 years |
| Disease Control Rate | To evaluate efficacy parameters such disease control rate (DCR) per RECIST 1.1, as assessed by investigater | 3 years |
| Duration of Response | To evaluate efficacy parameters such duration of response (DoR) per RECIST 1.1, as assessed by investigater | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haifeng Qin, PhD | Contact | +86 13601365243 | hifo@263.net | |
| Yongsheng Wang, PhD | Contact | wangy756@163.com |
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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 | 100039 | China |
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| Chongqing University Cancer Center | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 201321 | China |
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| West China School of Medicine/West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610064 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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