PHILADELPHIA, PA — Century Therapeutics, Inc. (NASDAQ: IPSC) has cemented a collaboration with renowned cell therapy leaders Professors Georg Schett and Andreas Mackensen to initiate a Phase 1/2 trial exploring its investigational cell therapy candidate, CNTY-101, for B-cell mediated autoimmune diseases. The trial, dubbed CARAMEL, will mark the first evaluation of an allogeneic iPSC-derived CD19-directed NK cell therapy in autoimmune disorders.
The investigator-initiated trial, sponsored by Friedrich-Alexander University Erlangen-Nürnberg, will investigate the safety and efficacy of CNTY-101 in challenging conditions such as systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis. This effort aligns with Century’s ongoing Phase 1 CALiPSO-1 trial, which similarly evaluates CNTY-101’s potential in autoimmune indications.
“We believe CNTY-101 is well positioned to address autoimmune diseases as an iPSC-derived NK cell therapy incorporating our Allo-Evasion™ technology for precise control over drug exposure,” said Brent Pfeiffenberger, Century’s Chief Executive Officer. “This collaboration with world-class experts underscores the innovative potential of CNTY-101 to offer transformative outcomes for patients.”
CNTY-101 is an off-the-shelf immunotherapy designed to eliminate logistical challenges tied to traditional treatments, such as high-cost apheresis and complex patient preparation. Dr. Andreas Mackensen, spearheading the trial, added, “We believe CNTY-101 holds immense promise as it reduces logistical hurdles and allows for outpatient administration. We look forward to working closely with Century to address significant patient needs.”
The CARAMEL trial is targeted to begin in mid-2025 following regulatory approval. It is expected to build on past groundbreaking research, conducted by the Schett/Mackensen group, which demonstrated the effectiveness of CD19 CAR-T cells in achieving sustained remissions in autoimmune diseases. The outcome of the trial could pave the way for transformational therapies in an area of high unmet patient need.
Century also plans to expand its CALiPSO-1 study into European sites, signaling a broader push toward driving CNTY-101’s development and accessibility for patients globally.
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