NEW YORK – Carsgen Therapeutics said on Monday that it will begin evaluating the autologous CAR T-cell therapy CT011 in patients with high-risk, stage IIIa, glypican-3 (GPC3)-positive liver cancer in China.
China's National Medical Products Administration (NMPA) cleared the Shanghai-based firm's investigational new drug application, allowing Carsgen to begin the China-based clinical trial in hepatocellular carcinoma patients following surgical resection.
In 2019, the NMPA cleared Carsgen's IND seeking permission to evaluate CT011 in patients with GPC3-positive solid tumors. The treatment is also undergoing testing in a Phase I investigator-sponsored clinical trial in China in patients with GPC3-positive liver cancer.
Carsgen is evaluating several other autologous CAR T-cell therapy candidates in China-based clinical trials. For instance, the firm is studying CT041 in patients with claudin (CLDN) 18.2-positive pancreatic cancer and in patients with advanced CLDN18.2-positive gastric and gastroesophageal cancers.
The firm has US-based trials underway, as well, including a Phase I study of the autologous CAR T-cell therapy CT071 in patients with relapsed or refractory multiple myeloma or primary plasma cell leukemia.