Supply of ciltakabtagen autoleucel for autologous cell therapy

Supply of cytostatic for CAR-T therapy (ciltakabtagen autoleucel): Infusion bag containing a cell dispersion of 3.2x10⁶ to 1x10⁸ viable anti-BCMA CAR-positive T-lymphocytes. The estimated annual volume is 10 infusion bags with an individually determined amount of active substance (ATC L01XL05), where one infusion bag is intended for single use. The medicinal product must meet the requirements of SÚKL (State Institute for Drug Control), and SÚKL registration is a necessary condition. It is intended for the treatment of adult patients with relapsed and refractory multiple myeloma who have undergone at least one previous therapy including an immunomodulator and a proteasome inhibitor, showed disease progression during the last treatment, and are refractory to lenalidomide. The contracting authority allows for the conclusion of separate contracts to regulate detailed cooperation conditions and responsibilities in the phases of the manufacturing and therapeutic process, including collection and processing of biological material, handling of the preparation, quality assurance, process documentation, qualification, and certification. These contracts must not contradict the conditions of the tender documents and the purchase agreement.

Tender documents

Additional details