Cargo Therapeutics to discontinue FIRCE-1 Phase 2 study of Firi-cel

Earlier this evening, the company stated: “CARGO Therapeutic announced that it has elected to discontinue FIRCE-1, a Phase 2 clinical study of firi-cel for patients with large B-cell lymphoma whose disease relapsed or was refractory to CD19 CAR T-cell therapy. In-line with this decision, the Company will reduce its workforce to extend cash runway and prioritize the advancement of CRG-023 to Phase 1 proof-of-concept data as well as its novel allogeneic platform. Based on an ad hoc analysis of FIRCE-1 prompted by recent safety events, the Company believes the results do not support a competitive benefit-risk profile of firi-cel for the intended patient population. While data from 51 patients with at least one post baseline scan demonstrated an overall response rate of 77% and complete response rate of 43%, the durability of CR at three months was 18%. Safety data indicated 18% of patients developed immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome that were grade 3 or higher, including grade 4 and grade 5 serious adverse events. IEC-HS is a toxicity that is associated with CAR T-cell therapy and firi-cel in other clinical studies. The Company is implementing a workforce reduction of approximately 50% to preserve cash. Further, CARGO will continue to advance CRG-023, its tri-specific CAR T, into a Phase 1 dose escalation study and its allogeneic platform to lead vector candidate selection while evaluating its strategic options. With preliminary cash, cash equivalents and marketable securities of $368.1M as of December 31, 2024, the Company expects its cash runway to be extended into mid-2028.” Shares of Cargo Therapeutics (CRGX) are down 76% afterhours at $3.16.