Autologous lymphocyte therapy (Biohealthcare)

A Phase I/II clinical study of the tolerability, safety, and preliminary efficacy of autologous lymphocyte injection (KACM001 injection) as an adjuvant therapy for patients with a high risk of recurrence after radical resection of hepatocellular carcinoma

The primary objective of the Phase I study was to evaluate the safety and tolerability of KACM001 autologous lymphocyte injection combined with PD-1 monoclonal antibody + XELOX in patients with locally advanced unresectable or metastatic gastric cancer, and to explore MTD and/or RP2D. The secondary objective of the Phase I study was to preliminarily evaluate the antitumor efficacy of KACM001 autologous lymphocyte injection combined with PD-1 monoclonal antibody + XELOX. The secondary objective of the Phase II study was to evaluate the antitumor efficacy of KACM001 autologous lymphocyte injection combined with PD-1 monoclonal antibody + XELOX by assessing overall survival (OS). The secondary objective of the Phase II study was to evaluate the antitumor efficacy of KACM001 autologous lymphocyte injection combined with PD-1 monoclonal antibody + XELOX by assessing other efficacy endpoints. The secondary objective of the Phase II study was to evaluate the safety and tolerability of KACM001 autologous lymphocyte injection combined with PD-1 monoclonal antibody + XELOX. To evaluate the biomarkers of KACM001 autologous lymphocyte injection combined with PD-1 monoclonal antibody + XELOX therapy.