Pharma Focus Asia

CARsgen's CT011 Secures NMPA Investigational New Drug Clearance for Stage Ⅲa Hepatocellular Carcinoma with High Recurrence Risk After Surgical Resection and GPC3 Positivity

Tuesday, January 16, 2024

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) has recently disclosed that its autologous CAR T-cell product candidate, CT011, which targets Glypican-3 (GPC3), has secured Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA). This clearance pertains specifically to patients with GPC3-positive stage IIIa hepatocellular carcinoma (HCC) who are at a high risk of recurrence following surgical resection.

Dr. Raffaele Baffa, Chief Medical Officer of CARsgen Therapeutics, underscored the importance of this achievement, highlighting the global prevalence of hepatocellular carcinoma as a primary form of liver cancer. GPC3 was identified as a promising target for CAR T-cell therapy, leading to the advancement of CT011 into clinical trials for HCC treatment. Notably, case reports have showcased disease-free survival for over seven years in patients with advanced hepatocellular carcinoma. Dr. Baffa expressed the company's dedication to exploring the potential of CAR-T for solid tumors, with the ultimate goal of providing innovative treatment options for patients.

CT011, designed as an autologous GPC3 CAR T-cell product for hepatocellular carcinoma treatment, received IND clearance from the NMPA in 2019, marking a significant milestone as China's first clearance for CAR T-cell therapy against solid tumors. CARsgen Therapeutics has successfully concluded the enrollment phase of a Phase I trial in China.



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