FDA News

FDA clears IND application for CAR T-cell therapy targeting gastric, pancreatic cancers

The FDA cleared an investigational new drug application for CT041, a chimeric antigen receptor T-cell therapy for the treatment of adenocarcinoma of the stomach, gastroesophageal junction or pancreas.

CT041 (CARsgen Therapeutics) is an autologous CAR T-cell therapy that targets claudin 18.2, a stomach-specific isoform of claudin 18 that is highly expressed in gastric and pancreatic adenocarcinomas.

"According to the World Health Organization, about 1,030,000 new cases of gastric adenocarcinoma and over 450,000 new cases of pancreatic adenocarcinoma are expected each year,” Zonghai Li, MD, PhD, founder, CEO and chief scientific officer of CARsgen, said in a press release. “Despite the development of novel therapies, gastric and pancreatic adenocarcinomas remain incurable and new treatment options are needed.”

The FDA’s IND clearance was based on the results of an ongoing phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics of anti-claudin 18.2 CAR T cells among patients whose tumors expressed claudin 18.2. As Healio previously reported, results presented at last year’s ASCO Annual Meeting showed a 33% overall response rate with an acceptable safety profile.

CARsgen plans to start enrollment in the third quarter of this year for an open-label, multicenter, phase 1b clinical trial to evaluate the safety and efficacy of CT041 among patients with advanced pancreatic or gastric adenocarcinoma.

 

The FDA cleared an investigational new drug application for CT041, a chimeric antigen receptor T-cell therapy for the treatment of adenocarcinoma of the stomach, gastroesophageal junction or pancreas.

CT041 (CARsgen Therapeutics) is an autologous CAR T-cell therapy that targets claudin 18.2, a stomach-specific isoform of claudin 18 that is highly expressed in gastric and pancreatic adenocarcinomas.

"According to the World Health Organization, about 1,030,000 new cases of gastric adenocarcinoma and over 450,000 new cases of pancreatic adenocarcinoma are expected each year,” Zonghai Li, MD, PhD, founder, CEO and chief scientific officer of CARsgen, said in a press release. “Despite the development of novel therapies, gastric and pancreatic adenocarcinomas remain incurable and new treatment options are needed.”

The FDA’s IND clearance was based on the results of an ongoing phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics of anti-claudin 18.2 CAR T cells among patients whose tumors expressed claudin 18.2. As Healio previously reported, results presented at last year’s ASCO Annual Meeting showed a 33% overall response rate with an acceptable safety profile.

CARsgen plans to start enrollment in the third quarter of this year for an open-label, multicenter, phase 1b clinical trial to evaluate the safety and efficacy of CT041 among patients with advanced pancreatic or gastric adenocarcinoma.

 

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