drugset / Trial / NCT05878028

L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC

NCT05878028 ↗

Phase 2 Unknown 33 enrolled Quanli Gao
NaSingle-groupOpen-labelTreatment

Summary

The goal of this observational study is to test in advanced non-small cell lung cancer patients with negative driver gene. For these patients, PD1 antibody therapy combined with chemotherapy was the preferred regimen. However, there is no standard regimen for the patients who refractory from the first-line PD1 inhibitor based therapy. The main questions they aim to answer are: 1.The efficacy of Liquid Tumor Infiltrating Lymphocytes (L-TIL) plus Tislelizumab and Docetaxel for patients failure from first line chemotherapy and PD1 inhibitor therapy. 2. The safety of L-TIL plus Tislelizumab and Docetaxel as second line therapy. All participants will receive four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab treatment except for disease progression, intolerable toxicity, withdrawal informed consent, death and so on.

Timeline

Start
2022-09-16
Primary completion
2025-09-15
Completion
2025-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject L-TIL Cell therapy 3e+09 cells Intravenous
Subject L-TIL Cell therapy 1e+10 cells Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous