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The study was terminated from a business perspective.
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This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT201 treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT201 injection in combination with teraplizumab injection | Biological | GT201 injection in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile Measured by Grade ≥3 TRAEs | To characterize the safety profile of autologous TIL injection (GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidience and severity of adverse events per CTCAE 5.0 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gobroad Hospital | Beijing | Beijing Municipality | China | |||
| Shanghai East Hospital |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Shanghai |
| Shanghai Municipality |
| 200120 |
| China |
| Shanghai GoBroad Cancer Hospital | Shanghai | Shanghai Municipality | 200120 | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |