Claudin18.2 CAR T Cells (CT041) Receives Approval to Initiate A Confirmatory Phase II Clinical Trial for advanced GC/GEJ in China
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, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has approved the initiation of the CT041 confirmatory Phase II clinical trial for the treatment of patients with Claudin18.2 (CLDN18.2) positive advanced gastric /gastroesophageal junction cancer (GC/GEJ) who have failed at least 2 prior lines of systemic therapies. The trial aims to evaluate the efficacy and safety of CT041 for the treatment of advanced GC/GEJ.
As of this announcement, CT041 is the world’s first and only CAR T-cell product candidate entering a confirmatory Phase II clinical trial for the treatment of solid tumors.
Professor Lin Shen M.D., Vice President of Peking University Cancer Hospital, Director of Department of Gastrointestinal Oncology, Director of Phase I Clinical Study Ward and Deputy Director of Beijing Institute for Cancer Research, the principal investigator, commented that, “Gastric cancer is one of the most common and deadly cancers in China, with an annual incidence about 500,000. However, the treatment options for gastric cancer patients who have failed at least two prior lines are very limited. The median progression-free survival (mPFS) of available therapies, including anti-PD-1 monoclonal antibody, is merely about two months, indicating an urgent unmet medical need for more innovative and effective drugs. In the early study of CT041 led by our center, as presented in the ESMO 2021, the mPFS of CT041 was over 5 months, which is very promising data. We are eager to start the study and will try our best to develop effective cellular therapies for cancer patients.”
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, commented that, “I would like to thank all the investigators and patients for their efforts in the clinical trials of CT041. With the approval of CT041 to initiate the confirmatory Phase II clinical trial of gastric cancer, we are one step further to successfully obtain the CT041 marketing authorization. With our continuous research and development, we believe that CT041 has a great potential to change the treatment paradigm for advanced gastric cancer worldwide.”
Source: CARsgen Therapeutics