SHANGHAI, June 4, 2024 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a biopharmaceutical enterprise, has announced the final outcomes of the CT041-CG4006 trial (NCT03874897) investigating satricabtagene autoleucel ("satri-cel," CT041), an autologous CAR T-cell therapy targeting Claudin18.2. These results have been published in Nature Medicine on June 3, 2024, and were also presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held on the same day. Further information can be found on the company's website.
Nature Medicine's article was titled "Claudin18.2-specific CAR T Cells in gastrointestinal cancers: phase 1 trial final results." The ASCO Annual Meeting abstract was named "Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Therapy for Patients with Gastrointestinal Cancers: Final Results of CT041-CG4006 Phase 1 Trial."
Professor Lin Shen of Beijing Cancer Hospital, the principal investigator, remarked, "Satri-cel has demonstrated promising efficacy and manageable safety in patients with Claudin18.2-positive advanced gastrointestinal cancers, especially those with gastric or gastroesophageal junction cancer. This study is a significant step forward in CAR T-cell therapy for solid tumors, indicating its potential to revolutionize current treatment paradigms and providing valuable insights for future research. We expect continued clinical trials and studies to further validate and enhance this innovative therapy, ultimately benefiting more patients."
Dr. Zonghai Li, Founder, Chairman, CEO, and CSO of CARsgen Therapeutics, expressed his satisfaction, stating, "We are pleased to share that the CT041-CG4006 study results have been simultaneously published in Nature Medicine and presented at the ASCO Annual Meeting. This study is a milestone in CAR T-cell therapy for solid tumors, underscoring the safety and effectiveness of satri-cel. We are grateful to the investigators for their dedication and to the patients and their families for their trust. Our collective aim is to offer better treatment options, and we will keep advancing the global clinical development of satri-cel to benefit more patients with gastric, pancreatic, and other gastrointestinal cancers."
About Satri-cel:
Satri-cel is an autologous CAR T-cell product targeting the protein Claudin18.2, potentially becoming the first product of its kind globally. It is being developed for Claudin18.2-positive solid tumors, primarily focusing on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Current trials include the CT041-CG4006 (NCT03874897), a Phase II confirmatory trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), a Phase I trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for advanced GC/GEJ with Claudin18.2-positive tumors in January 2022 and PRIME eligibility from the EMA for advanced gastric cancer in November 2021. It was also granted Orphan Drug designation by the U.S. FDA in 2020 and Orphan Medicinal Product designation by the EMA in 2021 for advanced gastric cancer.
About CARsgen Therapeutics Holdings Limited:
CARsgen is a biopharmaceutical company operating in China and the U.S., specializing in innovative CAR T-cell therapies for hematologic malignancies and solid tumors. The company has a comprehensive research and development platform, covering target discovery, CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has developed novel technologies and a global product pipeline to address key challenges in CAR T-cell therapies, such as enhancing safety, efficacy in treating solid tumors, and reducing treatment costs. CARsgen aims to be a global leader in biopharmaceuticals, delivering innovative and distinctive cell therapies to cure cancer worldwide.
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