Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of Combination of Anti-Programmed Cell Death Protein1 (Anti-PD1) Antibody-activated Autologous Tumor Infiltrating Lymphocytes (TILs) and Chemotherapy in the Treatment of Stage II-IIIA Non-small Cell Lung Cancer
This study was a phase I/II trial initiated by the investigator to evaluate the safety and tolerability of anti-PD-1 antibody-activated TILs combined with adjuvant chemotherapy in participants with stage II-IIIA non-small cell lung cancer. 20 participants were enrolled and anti-PD-1 antibody-activated TILs was infused into participants after the final cycle chemotherapy to assess the safety and disease-free survival.
Postoperative non-small cell lung cancer received 4 cycles of docetaxel and cisplatin regimen
adjuvant chemotherapy and received anti-PD1 antibody-activated TILs on the day 15 of the
final cycle of chemotherapy.
Fresh tumor tissues or sentinel lymph nodes were collected from participants with
postoperative non-small cell lung cancer, and the tumor tissues were digested with type IV
collagenase at 37 °C for 2 to 4 hours. The cell pellet was washed, suspended in medium
containing 10% AB serum, planted in a 24-well cell culture plate, and periodically changed
according to the growth of the cells. After culturing for 2 to 3 weeks, TILs were
co-stimulated with radioactively irradiated allogeneic peripheral blood mononuclear cells
（PBMCs）and were expanded in 100 ml of Interleukin-2 (IL-2) medium in a cell culture flask.
After rapid expansion for 15 days, the number of cells reached 0.1-1*10^10 cells. Before cell
transfer, TILs were incubated with anti-PD-1 antibody, and a fraction of the TILs were
collected to assess their number, phenotype, and viability of cells, and to test for possible
contamination by bacteria, fungi, or endotoxins. Then, autologous TILs (0.1-1*10^10 cells)
were transferred to participants via intravenous infusion.
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