On June 4, 2024 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, reported that the final follow-up results of the investigator-initiated trial CT041-CG4006 (NCT03874897) of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2) have been published in Nature Medicine on June 3, 2024. Data were presented as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting on June 3, 2024, 12:30 pm-3:30 pm, Eastern Daylight Time (Press release, Carsgen Therapeutics, JUN 4, 2024, View Source [SID1234644102]). Further details have been posted on the corporate website View Source
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The article in Nature Medicine was titled "Claudin18.2-specific CAR T Cells in gastrointestinal cancers: phase 1 trial final results".[1]
The 2024 ASCO (Free ASCO Whitepaper) Annual Meeting abstract was titled "Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Therapy for Patients with Gastrointestinal Cancers: Final Results of CT041-CG4006 Phase 1 Trial".[2]
The leading PI of this study, Professor Lin Shen of Beijing Cancer Hospital, said, "Satri-cel has shown promising efficacy and manageable safety profiles in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly those with gastric cancer or gastroesophageal junction cancer. This study marks a significant advancement in the field of CAR T-cell therapy for solid tumors. It suggests that CAR T-cell therapy has the potential to transform existing treatment paradigms and provides important reference points for further innovative research. In the future, we anticipate that more clinical trials and studies will further validate and refine this innovative therapy, enabling it to benefit a broader patient population as soon as possible."
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are delighted to announce that the final results of the CT041-CG4006 study have been simultaneously published in the prestigious journal Nature Medicine and reported as an oral presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting. This study represents a significant milestone in the field of CAR T-cell therapy for solid tumors, demonstrating the encouraging safety and efficacy of satri-cel. We extend our heartfelt thanks to the investigators for their years of dedicated efforts, and to the patients and their families for their trust and support. It is our shared goal to provide better treatment options for patients, and we will continue to advance the global clinical development of satri-cel, ensuring this innovative CAR T-cell therapy benefits more patients with gastric, pancreatic, and other gastrointestinal cancers."
About Satri-cel
Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that can potentially be the first-in-class globally. Satri-cel has been developed for the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in November 2021. Satri-cel received an Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and an Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer.