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The clinical trial “GAIA-102 Intraperitoneal Administration in Patients with Advanced Gastrointestinal Cancer of Microsatellite Stable with Malignant Ascites” has been adopted by AMED as part of ’Research Project for Practical Applications of Regenerative Medicine’.
Fukuoka, JAPAN – Principal research scientist Professor Yoshi Yonemitsu, MD, PhD (Department of Innovative Biomedicine for Drug Discovery at Graduate School of Pharmaceutical Sciences, Kyushu University, and he is concurrently serving CTO/CSO of GAIA BioMedicine Inc.), in collaboration with Kyushu University Hospital (Principal Investigator: Dr. Eiji Oki) is conducting the clinical trial “GAIA-102 Intraperitoneal Administration in Patients with Advanced Gastrointestinal Cancer of Microsatellite Stable with Malignant Ascites” (https://gaia-biomed.com/news/2347/), which has been selected for the fiscal year 2024 ’Research Project for Practical Applications of Regenerative Medicine’ by the Japan Agency for Medical Research and Development (AMED). In this investigator-initiated clinical trial, GAIA BioMedicine Inc. (‘GAIA’) supplies GAIA-102.
Abstract
Gastric cancer is the third most common malignant tumor in Japan. As the disease progresses, it often manifests as peritoneal dissemination and ascites, leading to resistance to chemotherapy and deterioration of patient’s quality of life (QOL). Controlling peritoneal dissemination is a critical challenge in treating advanced, or recurrent stomach cancer, yet it remains a refractory condition without effective treatment options. This research anticipates obtaining significant data to establish an effective treatment regimen for various intractable solid tumors by demonstrating the efficacy of NK cell-like cells ‘GAIA-102’, manufactured by GAIA against advanced solid tumors.
Research Objectives
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- <First-Year Goal> Complete the ongoing Phase I part (remaining 12 cases), confirming the safety of GAIA-102 monotherapy and Pembrolizumab combination therapy in patients with MSS advanced gastrointestinal cancer (stomach and pancreatic cancers) with malignant ascites, and determine the recommended dosing regimen for Phase II.
The number of medical institutions participating in this study is to extend to 6 or more hospitals during Phase I. - <Goals for the Second Year and Beyond> Focus on stomach cancer and complete the Phase II part (randomized comparative trial with a planned enrollment of 30 cases) using the recommended regimen.
- <First-Year Goal> Complete the ongoing Phase I part (remaining 12 cases), confirming the safety of GAIA-102 monotherapy and Pembrolizumab combination therapy in patients with MSS advanced gastrointestinal cancer (stomach and pancreatic cancers) with malignant ascites, and determine the recommended dosing regimen for Phase II.
Selected Research Project Overview
Project Name: Research Project for Practical Applications of Regenerative Medicine
Organization: Japan Agency for Medical Research and Development (AMED)
Research Focus: Developing regenerative medicine and related products originating from academia, in collaboration with industry
Research Project: GAIA-102 Intraperitoneal Administration in Patients with Advanced Gastrointestinal Cancer of Microsatellite Stable with Malignant Ascites
Lead Institution: Kyushu University
Principal Investigator: Prof. Yoshikazu YONEMITSU, MD PhD, Kyushu University Faculty of Pharmaceutical Sciences
Research Duration: 2024 to 2029 (5 years)
About GAIA BioMedicine Inc.
GAIA BioMedicine, Inc., founded in 2015 by Prof. Yoshikazu YONEMITSU, MD PhD, a spin-off venture of Kyushu University, is a clinical-stage and technology-driven biopharmaceutical company specializing in cell therapies for cancer using NK cells.
https://www.amed.go.jp/koubo/13/01/1301C_00047.html
