CARsgen Reports Positive Phase II Results for Claudin18.2 CAR-T in China Trial

SHANGHAI, Dec. 30, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited, listed under the stock code 2171.HK, has announced promising outcomes from their critical Phase II clinical trial, CT041-ST-01 (NCT04581473). The trial is an open-label, multicenter study designed to assess both the safety and efficacy of satricabtagene autoleucel ("satri-cel", CT041), an innovative CAR T-cell therapy targeting Claudin18.2, in patients with advanced gastric or gastroesophageal junction cancers who have not responded to at least two previous therapies. Participants in the trial were randomly divided into a 2:1 ratio, receiving either the satricabtagene autoleucel infusion or a treatment selected by their physician, which could include medications such as paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab.

The study's primary endpoint was progression-free survival (PFS), assessed by an Independent Review Committee (IRC). The results revealed a statistically significant improvement in PFS for patients treated with satri-cel compared to those who received the physician's choice treatment. Furthermore, earlier data established that the safety profile of satricabtagene autoleucel was manageable, suggesting a positive risk-benefit ratio for this treatment.

Dr. Zonghai Li, the Founder, Chairman, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, expressed his excitement about the trial's outcomes. He highlighted the significance of these results for gastric cancer patients who have previously failed multiple treatments, noting that satri-cel could become a pioneering CAR-T therapy for solid tumors. Dr. Li also revealed plans to submit a New Drug Application to the National Medical Products Administration (NMPA) in the first half of 2025, with hopes that satri-cel will soon be available to patients globally. CARsgen Therapeutics is also exploring the use of satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to extend its benefits to a broader patient population.

Satri-cel is an autologous CAR T-cell product candidate that targets Claudin18.2, a protein associated with certain solid tumors. The therapy focuses primarily on treating gastric cancer/gastroesophageal junction cancer and pancreatic cancer. Several clinical trials are underway, including investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II trial in China for advanced gastric/gastroesophageal junction cancer (CT041-ST-01, NCT04581473), and a Phase I clinical trial for pancreatic cancer adjuvant therapy in China (CT041-ST-05, NCT05911217). Additionally, a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma is being conducted in North America (CT041-ST-02, NCT04404595).

In January 2022, satri-cel received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for treating advanced gastric/gastroesophageal junction cancer with Claudin18.2-positive tumors. Furthermore, the U.S. FDA granted satri-cel Orphan Drug designation in 2020 for the treatment of gastric/gastroesophageal junction cancer.

CARsgen Therapeutics Holdings Limited is a biopharmaceutical company operating in both China and the United States, dedicated to innovative CAR T-cell therapies for hematologic malignancies and solid tumors. The company boasts a comprehensive CAR T-cell research and development platform, which spans target discovery, therapy development, clinical trials, and commercial-scale production. CARsgen is committed to overcoming existing challenges in CAR T-cell therapies by enhancing safety, increasing efficacy in treating solid tumors, and reducing treatment costs. Its mission is to establish itself as a global leader in biopharmaceuticals, offering groundbreaking and differentiated cell therapies to cancer patients worldwide, with the ultimate goal of eradicating cancer.