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| Name | Class |
|---|---|
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
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This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIL injection treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIL injection | Biological | Autologous tumor infiltrating lymphocyte injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events per CTCAE 5.0 | To characterize the safety profile of autologous TIL injection (GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adverse events per CTCAE 5.0 | From TIL infusion to the 24th week |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 and iRECIST as assessed by the investigator. | Up to 24 months post infusion |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengxiang Han, PHD | Contact | +86 18052268612 | cnhzxyq@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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| ID | Term |
|---|---|
| D051194 | Toll-Like Receptor 1 |
| ID | Term |
|---|---|
| D051193 | Toll-Like Receptors |
| D051192 | Receptors, Pattern Recognition |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
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To evaluate the percentage of participants that achieved partial response (PR), complete response (CR), or stable disease (SD) after treatment among total number of evaluable patients. |
| Up to 24 months post infusion |
| Progression-free survival (PFS) | To evaluate the time from the date of TIL infusion until disease progression per RECIST v1.1 and iRECIST as assessed by the investigator or death due to any cause. | Up to 24 months post infusion |
| Duration of Response (DoR) | To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 and iRECIST as assessed by the investigator until disease progression or death due to any cause. | Up to 24 months post infusion |
| Overall survival (OS) | To evaluate the time from the date of TIL infusion to death due to any cause. | From the date of TIL infusion to date of death due to any cause, or up to 24 months post infusion (whichever occurs first) |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |