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This study is an open, single-arm, dose-escalating phase I exploratory clinical trial to observe the safety, tolerability and preliminary efficacy of different doses of TILs in the treatment of relapsed and refractory NSCLC(Non-small cell lung cancer).
The study includes 7 stages: ①screening period; ② tissue collection; ③ TILs cell production and preparation; ④ lymphocyte depletion pretreatment; ⑤ TILs cell infusion; ⑥ safety and efficacy evaluation; ⑦ follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TILs(Tumor Infiltrating Lymphocytes) | Drug | 10e9, 10e10, 10e11 dose range of TILs, 3+3 dose escalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT(Dose limiting toxicity) | The severity of adverse events is graded according to NCT-CTCAE version 5.0, and the investigator will determine whether the subject has DLT. DLT is defined as: Grade 3 or above (CTCAE version 5.0) possible or confirmed related symptoms, laboratory toxicity and clinical events caused by the study treatment within 28 days after transfusion of TILs cells. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate, ORR | To evaluate the efficacy of TILs in patients with NSCLC based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 3 Months |
| Duration of Response, DOR |
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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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To evaluate the efficacy parameters of TILs in patients with NSCLC by assessing duration of response (DOR) as assessed by the IRC per RECIST v1.1 |
| 2 years |
| Progression-Free Survival, PFS | To evaluate the efficacy parameters of TILs in patients with NSCLC by assessing progression-free survival (PFS) as assessed by the IRC per RECIST v1.1 | 2 years |
| overall survival, OS | To evaluate overall survival (OS) in patients with NSCLC | 2 years |
| Disease Control Rate, DCR | To evaluate the efficacy of TILs in patients with NSCLC by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1 | 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |