CARsgen Therapeutics has announced that its autologous CAR T-cell product candidate, CT011, received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) in China.
The IND clearance has been received for patients with GPC3-positive stage IIIa hepatocellular carcinoma at high risk of recurrence after surgical resection.
CT011 is designed to target Glypican-3 (GPC3), a protein associated with hepatocellular carcinoma (HCC).
CARsgen Therapeutics chief medical officer Raffaele Baffa said: “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.”
In 2019, the therapy obtained IND clearance from the NMPA to treat GPC3-positive solid tumours, becoming the first CAR T-cell therapy against solid tumours to achieve this in China.
Following this clearance, CARsgen successfully completed enrolment for a Phase I trial in the country.
Last year, CARsgen collaborated with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China.
The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 aims to treat relapsed/refractory multiple myeloma (R/R MM).
CARsgen has operations in the US and China and is focused on CAR T-cell therapies to treat haematologic malignancies as well as solid tumours.