CARsgen’s CT011 achieves IND clearance from the NMPA for the GPC3-positive stage Ⅲa hepatocellular carcinoma at high risk of recurrence after surgical resection

On January 15, 2024 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that CT011, an autologous CAR T-cell product candidate against Glypican-3 (GPC3), has achieved Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) for patients with GPC3-positive stage IIIa hepatocellular carcinoma who are at high risk of recurrence after surgical resection (Press release, Carsgen Therapeutics, JAN 15, 2024, View Source [SID1234639237]).

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Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, commented, "Hepatocellular carcinoma (HCC) stands as the predominant histologic subtype of primary liver cancer, ranking as the sixth most prevalent cancer type globally. We initially identified GPC3 as a viable target for CAR T-cell therapy and subsequently progressed it to clinical trials for the treatment of HCC. Case report has shown patients with advanced hepatocellular carcinoma have achieved disease-free survival for more than seven years. We will continue to explore the potential of CAR-T for solid tumors and bring new treatment options for patients."

About CT011

CT011 is an autologous GPC3 CAR T-cell product candidate for the treatment of hepatocellular carcinoma (HCC). CT011 received IND clearance from the NMPA in 2019 for the treatment of patients with GPC3-positive solid tumor which was China’s first IND clearance for CAR T-cell therapy against solid tumors. CARsgen have completed enrollment of a Phase I trial in China.