CARsgen Completes Enrollment in China Phase II Trial for Claudin18.2 CAR T (Satri-cel)

CARsgen Therapeutics Holdings Limited, listed on the Hong Kong Stock Exchange under the code 2171.HK, has announced the successful completion of enrollment for the pivotal Phase II clinical trial of their CAR T-cell therapy candidate, satricabtagene autoleucel (satri-cel, R&D code: CT041). This therapy, geared towards treating advanced gastric and gastroesophageal junction (GC/GEJ) cancers, targets the protein Claudin18.2. The trial, conducted in China, is a significant step in developing new treatments for these challenging cancers.

The trial is an open-label, multicenter, randomized study focusing on patients with Claudin18.2-positive advanced GC/GEJ who have not responded to at least two previous lines of therapy. The control arm offers treatments selected by the physician, including options like paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab.

Gastric cancer remains a prevalent and deadly disease in China, with an estimated 359,000 new cases and about 260,000 deaths in 2022. For patients with advanced stages of gastric cancer, treatment options are limited, and prognoses are generally poor. Therefore, there is an urgent need for innovative treatments. Satri-cel represents a potential first-in-class CAR T-cell therapy for Claudin18.2-positive solid tumors, particularly focusing on GC/GEJ and pancreatic cancer (PC). Early clinical data have shown substantial promise in terms of both safety and efficacy.

The Phase I clinical trial CT041-CG4006 (NCT03874897) results, published in Nature Medicine and presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, highlighted the therapy's potential. In this trial, 51 patients with GC/GEJ who received satri-cel showed an overall response rate (ORR) of 54.9% and a disease control rate (DCR) of 96.1%, with a median duration of response (mDOR) of 6.4 months. Importantly, no dose-limiting toxicities (DLTs), Grade 3 or higher cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.

Further validation came from the Phase Ib trial CT041-ST-01 (NCT04581473) results presented at the 2022 ASCO annual meeting. Among 14 GC/GEJ patients treated with satri-cel, who had failed at least two previous treatments, the therapy showed no DLTs or adverse effects leading to death, and no cases of ICANS or gastrointestinal mucosal injury. The ORR was 57.1%, and the DCR was 78.6%, further underscoring the promising efficacy and manageable safety profile of satri-cel.

Dr. Zonghai Li, the Founder, Chairman, CEO, and Chief Scientific Officer of CARsgen Therapeutics, expressed satisfaction with the milestone achievement of completing patient enrollment in the pivotal Phase II trial. He acknowledged the hard work of the investigators and the trust of the patients and their families. Dr. Li emphasized the company's commitment to pushing forward with the New Drug Application and seeking approval in China to provide new treatment options for gastric cancer patients. He reiterated CARsgen's dedication to overcoming the challenges faced by existing CAR T-cell therapies and its mission to develop innovative products for cancer care.

Satri-cel targets Claudin18.2-positive solid tumors with a particular focus on GC/GEJ and PC. The therapy has received several designations, including Regenerative Medicine Advanced Therapy (RMAT) by the U.S. FDA, PRIME eligibility by the EMA, and orphan drug designations from both the U.S. FDA and EMA. These recognitions highlight its potential significance in the treatment landscape for these difficult-to-treat cancers.

CARsgen Therapeutics continues to expand its research and development efforts in the field of CAR T-cell therapies, aiming to address the significant unmet needs in cancer treatment. The company has developed a robust pipeline and innovative technology platform, striving to improve the safety, efficacy, and accessibility of CAR T-cell therapies for patients worldwide.

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