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CARGO Therapeutics to Discontinue FIRCE-1 Phase 2 Study of Firi-cel; Advances Remaining Programs While Evaluating Strategic Options

Core Insights - CARGO Therapeutics has decided to discontinue the FIRCE-1 Phase 2 clinical study of firi-cel for large B-cell lymphoma patients due to unsatisfactory results regarding the benefit-risk profile [1][6] - The company will implement a workforce reduction of approximately 50% to extend its cash runway and focus on advancing its CRG-023 candidate and allogeneic platform [3][6] Study Results - The FIRCE-1 study showed an overall response rate of 77% and a complete response rate of 43% among 51 patients, but the durability of complete response at three months was only 18% [2] - Safety concerns were highlighted, with 18% of patients experiencing grade 3 or higher immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome [2][4] Financial Position - As of December 31, 2024, CARGO had preliminary cash, cash equivalents, and marketable securities totaling $368.1 million, which is expected to fund operations into mid-2028 [3][8] - The workforce reduction aims to preserve cash while continuing the development of CRG-023 and the allogeneic platform [3][6] Future Plans - CARGO intends to advance CRG-023 into a Phase 1 dose escalation study, with enrollment expected to begin in Q2 2025 [6] - The company will evaluate strategic options while continuing to collaborate with stakeholders involved in the FIRCE-1 study [4][6]