Autologous lymphocyte therapy (Biohealthcare)

Phase I study Main study objective: To evaluate the safety and tolerability of KACM001 autologous lymphocyte injection during chemotherapy in subjects with locally advanced unresectable or metastatic gastric cancer, and to explore the MTD (maximum tolerated dose) and/or RP2D (recommended dose for Phase II clinical studies). Secondary study objective: To preliminarily evaluate the anti-tumor efficacy of KACM001 autologous lymphocyte injection combined with chemotherapy. Exploratory study objective: To explore the characteristic parameters of KACM001 autologous lymphocyte injection in vivo after infusion. Phase II study Main study objective: To evaluate the anti-tumor efficacy of KACM001 autologous lymphocyte injection on locally advanced unresectable or metastatic gastric cancer. Secondary study objective: To evaluate other anti-tumor efficacy of KACM001 autologous lymphocyte injection on locally advanced unresectable or metastatic gastric cancer. To evaluate the safety and tolerability of KACM001 autologous lymphocyte injection on locally advanced unresectable or metastatic gastric cancer.