Group 1 - Stansai Biotech has successfully completed the key dose escalation trial of its GCC19CART for patients with refractory metastatic colorectal cancer in the United States [1][2] - The trial involved 12 participants, with 6 (54.5%) achieving objective response, and at the higher dose level of 2×10^6 CAR-T cells/kg, 4 out of 5 (80%) patients achieved objective response with a median duration of response of 6.9 months [1][2] - The company aims to discuss the next steps for clinical development of GCC19CART with the FDA, targeting colorectal cancer and other solid tumors expressing GCC [2][3] Group 2 - GCC19CART is developed based on Stansai's proprietary CoupledCAR platform technology, specifically targeting colorectal cancer and showing unprecedented anti-tumor activity in difficult-to-treat cases [2] - The company has achieved a 100% success rate in its Maryland manufacturing facility, ensuring seamless scalability for future clinical and commercial production needs [2] - Stansai is also expanding its product pipeline to include other solid tumors, such as prostate cancer, with promising clinical activity demonstrated in its PAP CAR-T product [3]
关键里程碑达成!治疗晚期结直肠癌产品GCC19CART美国 I 期临床达成既定目标
Zhong Guo Chan Ye Jing Ji Xin Xi Wang·2025-08-13 08:00