NEW YORK – Senti Biosciences said Monday that the first liver cancer patient has been treated with its investigational CAR-NK cell therapy, SN301A, in a Phase I clinical trial in China.
The South San Francisco, California-based firm is collaborating with Shanghai-based Celest Therapeutics to develop the off-the-shelf cell therapy for patients with advanced glypican 3 (GPC3)-expressing hepatocellular carcinoma.
The trial is designed to evaluate the safety and preliminary anti-tumor activity of SN301A, which is called SENTI-301A outside China. The treatment involves donor-derived natural killer cells manufactured to express a chimeric antigen receptor that targets the GPC3 antigen on hepatocellular carcinoma cells. The treatment also involves a calibrated release of interleukin-15 intended to stimulate the immune cells surrounding the cancer and promote the expansion, persistence, and tumor-killing of the CAR-NK cells.
In the Phase I study, an estimated 12 hepatocellular carcinoma patients whose tumors express GPC3 as determined by immunohistochemistry testing will receive lymphodepleting chemotherapy followed by three dose levels of SN301A in cycles involving three weekly doses. Patients may continue receiving the treatment based on their responses.
In the collaboration, Celest is leading the clinical development, operations, and manufacturing of SN301A, and Senti Bio is providing technical, strategic, and clinical input. Senti Bio will retain all development and commercial rights to the treatment outside mainland China, Hong Kong, Macau, and Taiwan. Although the trial is taking place at a single site in China, the partnered firms have the option to expand SN301A's development into Hong Kong, Macau, and Taiwan.
Senti Bio said in a statement that the initial data on SN301A suggest that there may be opportunities to expand the treatment to other solid tumor indications.