drugset / Trial / NCT04919616

An Exploratory Clinical Study of TILs in the Treatment of Recurrent / Refractory Non-small Cell Lung Cancer (NSCLC)

NCT04919616

Phase 0 Unknown 15 enrolled Shanghai OriginCell Therapeutics Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

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: ① screening 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.

Timeline

Start
2021-06-15
Primary completion
2023-06-15
Completion
2025-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+10 cells
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+11 cells
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+12 cells