CARsgen Therapeutics Holdings Limited, a prominent player in the field of CAR T-cell therapies, has announced the successful completion of patient enrollment for its pivotal Phase II clinical trial of Satri-cel (satricabtagene autoleucel). This advanced autologous CAR T-cell product candidate targets Claudin18.2 and aims to treat patients with advanced gastric and gastroesophageal junction cancers (GC/GEJ) in China.

Breakthrough for Advanced Gastric Cancer

The Phase II trial, an open-label, multicenter, randomized study, is set to evaluate the efficacy and safety of Satri-cel in patients with Claudin18.2-positive advanced GC/GEJ who have previously failed at least two lines of therapy. The control group will receive treatments such as paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab, as chosen by their physicians. This trial is crucial given the high incidence and mortality of gastric cancer in China, where approximately 359,000 new cases and 260,000 deaths were reported in 2022.

Advanced gastric cancer patients often experience a poor prognosis and limited treatment options, underscoring the need for innovative therapies. Satri-cel, which targets Claudin18.2—a protein expressed in many solid tumors—has the potential to be a groundbreaking therapy for these patients.

Promising Early Data

Satri-cel has shown significant promise in earlier trials. The Phase I trial, CT041-CG4006, published in Nature Medicine and presented at the 2024 ASCO Annual Meeting, demonstrated impressive results. The trial reported no dose-limiting toxicities or severe cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Among 51 patients with GC/GEJ who received Satri-cel monotherapy, the overall response rate (ORR) was 54.9%, with a disease control rate (DCR) of 96.1% and a median duration of response (mDOR) of 6.4 months.

Further, the Phase Ib results from CT041-ST-01, presented at the 2022 ASCO Annual Meeting, supported these findings. In a cohort of 14 GC/GEJ patients who had received at least two prior treatments, Satri-cel demonstrated manageable safety and promising efficacy, with an ORR of 57.1% and a DCR of 78.6%. Notably, no dose-limiting toxicities or adverse events leading to death were reported.

Expert Insights and Future Prospects

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, expressed his enthusiasm about reaching this milestone. He emphasized that the completion of enrollment is a significant step forward in advancing CAR T-cell therapies for solid tumors. Dr. Li acknowledged the contributions of the investigators, patients, and their families, and expressed anticipation for the New Drug Application submission and potential approval in China.

Satri-cel’s development aligns with CARsgen’s broader strategy to address the unmet needs in cancer treatment. The company’s commitment to innovation is reflected in its ongoing trials for Satri-cel, including studies for pancreatic cancer and advanced gastric cancer in North America. In addition to its promising clinical data, Satri-cel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA and PRIME eligibility from the EMA, highlighting its potential as a transformative therapy.

Additional Context and Industry Impact

Gastric cancer remains a global health challenge, with varying incidence and mortality rates across different regions. In addition to its significant burden in China, gastric cancer is a major concern in other parts of Asia and the world. The need for effective therapies is acute, given the limited success of current treatment options for advanced stages of the disease.

CARsgen Therapeutics’ Satri-cel could potentially redefine treatment paradigms, offering new hope to patients with few alternatives. The innovation in targeting Claudin18.2 could lead to improved outcomes and survival rates, setting a new standard in cancer care.

The completion of enrollment in the pivotal Phase II trial of Satri-cel by CARsgen Therapeutics represents a notable advancement in the fight against advanced gastric cancer. As the trial progresses, the results could pave the way for a new, effective treatment option for Claudin18.2-positive cancers, offering hope to patients facing challenging diagnoses.

  cancer therapy, CARsgen Therapeutics, Claudin18.2, clinical trial, gastric cancer, Gastroesophageal junction cancer, Phase II, Regenerative Medicine Advanced Therapy, Satri-cel