Core Insights - Century Therapeutics has initiated an investigator-initiated trial (IIT) for its CD19 CAR-iNK cell therapy candidate CNTY-101, targeting B-cell mediated autoimmune diseases, led by the Schett/Mackensen group at Friedrich-Alexander University Erlangen-Nürnberg [1][2][3] Group 1: Trial Details - The IIT, named the CARAMEL trial, will assess the safety, efficacy, and key translational data of CNTY-101 in conditions such as systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis [2][4] - The trial is set to commence in mid-2025, pending approval from the relevant authorities [4] Group 2: Company Positioning - Century Therapeutics emphasizes the unique potential of CNTY-101 in treating autoimmune diseases, leveraging its Allo-EvasionTM technology for precise control over drug exposure, supported by pre-clinical and clinical data demonstrating anti-B cell activity and a favorable safety profile [3][4] - The company plans to expand its ongoing Phase 1 CALiPSO-1 trial to include sites in select European countries, with updates on initial clinical data to follow as patient enrollment progresses [5] Group 3: Expert Commentary - Dr. Andreas Mackensen highlighted the promise of allogeneic iPSC-derived cell therapy like CNTY-101, noting its advantages such as eliminating logistical hurdles and potential for outpatient administration [4] - The Schett/Mackensen group has a history of pioneering cell therapy in autoimmune diseases, having previously demonstrated significant outcomes with autologous CD19 CAR-T cell therapy [4]
Century Therapeutics Announces Investigator-Initiated Phase 1/2 Trial of its iPSC-derived iNK Cell Therapy CNTY-101 in B-cell Mediated Autoimmune Diseases Sponsored by Internationally Renowned Key Opinion Leaders