1470TiP - Phase I trial of intraperitoneal infusion of GAIA-102 of NK-Like CD3-negative cells for gastric/pancreatic cancer

Background

CAR-T therapy for solid tumors has not yet been firmly established, largely due to challenges in effectively reaching tumor sites. GAIA-102, an off-the-shelf product containing highly purified, allogeneic NK-like CD3-negative cells, shows promise in exerting anti-tumor effects against solid tumors.

Trial design

This study aims to investigate the safety and efficacy of intraperitoneal GAIA-102 administration for gastric and pancreatic cancers, in the presence of malignant ascites. This phase I clinical trial targets histologically diagnosed patients with gastric or pancreatic cancer accompanied by malignant ascites. Gastric cancer patients must have previously undergone three lines of treatments, while pancreatic cancer received two lines. In the eligible patient, an abdominal port is implanted under general anesthesia. The phase I component employs a 3 + 3 design, consisting of a single-agent cohort and a combination cohort with pembrolizumab, involving a 4-week treatment regimen with GAIA-102 administered intraperitoneally once to three times a week for three consecutive weeks, followed by a one-week treatment-free interval. Dose-limiting toxicity (DLT) will be assessed up to day 28 to ensure safety. The primary endpoints include the occurrence of DLT and an evaluation of the frequency and severity of adverse events. This represents the world's inaugural trial of cell therapy specifically targeting peritoneal dissemination in gastric and pancreas cancer, distinct from CAR-T therapy or NK cells. In phase 1, several cases have already shown reduction of the disseminated nodules on imaging. The progress of the trial will be presented. A phase II trial is planned with 6-month survival as the primary endpoint.

Clinical trial identification

jRCT2073220017.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Research Grant of Japan Agency for Medical Research and Development (AMED).

Disclosure

E. Oki: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eli Lilly, Bristol Myers Squibb, MSD, Takeda Pham; Financial Interests, Institutional, Research Grant: Guardant Health. All other authors have declared no conflicts of interest.