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This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT307 injection treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT307 injection | Biological | GT307 injection to treat solid tumours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adcersed events per CTCAE 5.0 | To characterize the safety profile of autologous TIL injection(GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang Yu, PHD | Contact | +86 (021)63455050 | 8571 | kangyu1489@fckyy.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics & Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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