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28 participants are expected to be enrolled for the Phase II clinical trial, this trial is expected to be finished in 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Participants with advanced NSCLC using cryopreserved GC101 TIL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Tumor Infiltrating Lymphocytes | Biological | A tumor sample is resected from each participant and cultured ex vivo to generate tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC101 TIL followed low-dose PD-1 antibody. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria) | 18 weeks |
| Progression-Free Survival | Evaluate the efficacy endpoints of PFS by the investigator with RECIST | Maximum 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST | Maximum 36 months |
| Duration of Response | Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Maximum 36 months |
| Overall survival | Evaluate the efficacy endpoints of OS | Maximum 60 months |
| Adverse Events | Incidence of adverse events associated with GC101 TIL infusion | Maximum 360 days |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |