Clinical Trials and Study Progress - 71 patients have been dosed in the potentially pivotal Phase 2 clinical study of firicabtagene autoleucel (firi-cel), with interim analysis results expected in 1H'25[4] - FDA cleared the IND application for CRG-023, a tri-specific CAR T, with Phase 1 study enrollment expected to initiate mid-year 2025[4] - CRG-023 Phase 1 study will begin at a dose level of 25 million cells, informed by preclinical data showing in vivo tumor clearance at low dose levels[6] - CARGO expects to share topline data from an interim analysis of firi-cel with at least 3 months of follow-up in 1H'25[10] CAR T-Cell Therapy Development - CARGO's novel allogeneic platform is designed to limit immune-based rejection and enable durable response of CAR T-cell therapy, with lead vector candidate selection expected in 1H'25[7] - CRG-023 is a first-of-its-kind CAR T to express three independent CARs (CD19, CD20, CD22) from a single vector, each with a distinct co-stimulatory domain[10] - The novel allogeneic platform aims to transform autologous CAR T-cell therapies into allogeneic products, leveraging existing autologous drug product processes[7] - CRG-023 drug product is produced using CARGO's internally developed process and analytical methods, with a suspension culture process providing commercially suitable expression levels[10] Strategic Plans and Financials - CARGO plans to leverage proof-of-concept data from CRG-023 to support moving quickly into earlier lines of therapy and additional indications in B-cell malignancies[10] - CARGO's preliminary cash, cash equivalents, and marketable securities were $368.1 million as of December 31, 2024, expected to fund operations through 2026[11]
Cargo Therapeutics(CRGX) - 2024 Q4 - Annual Results