Century Therapeutics has announced an investigator-initiated Phase 1/2 trial (IIT) to evaluate its CD19 CAR-iNK cell therapy candidate, CNTY-101, in patients with B-cell mediated autoimmune diseases. The trial, sponsored by Friedrich-Alexander University Erlangen-Nürnberg and led by Professors Georg Schett and Andreas Mackensen, marks the first evaluation of an allogeneic iPSC-derived CD19-directed NK cell therapy for autoimmune conditions by the Schett/Mackensen group. The study aims to assess the safety, efficacy, and translational data of CNTY-101 in systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis.
CARAMEL Trial Details
The IIT, named the CARAMEL trial, will explore CNTY-101's potential in addressing the unmet needs of patients with severe autoimmune diseases. CNTY-101, a chimeric antigen receptor (CAR) therapy derived from induced pluripotent stem cells (iPSCs), is engineered to target and eliminate B cells, which play a critical role in the production of autoantibodies and disease activity in lupus and other autoimmune disorders. This therapy is the first of its kind to incorporate six gene edits, enhancing its ability to destroy infected and diseased cells.
Expert Perspectives
Dr. Andreas Mackensen, Director of Medical Clinic 5 – Hematology & Internal Oncology at Friedrich-Alexander University Erlangen-Nürnberg, stated, "We believe allogeneic iPSC-derived cell therapy with a consistent, off-the-shelf product like CNTY-101 holds immense promise in the treatment of autoimmune diseases, driven by the elimination of logistical hurdles such as apheresis, removal of washout concerns, and the potential for administration in outpatient settings."
Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics, added, "We believe CNTY-101 is well positioned to address autoimmune diseases as an iPSC-derived NK cell therapy incorporating our Allo-EvasionTM technology for precise control over drug exposure, as supported by pre-clinical and clinical data demonstrating clear anti-B cell activity and an encouraging safety profile."
Background and Significance
The Schett/Mackensen group previously demonstrated the potential of cell therapy in autoimmune diseases, with data showing that autologous CD19 CAR-T cell therapy achieved deep depletion of B-cells, leading to long-term, drug-free remission in patients with severe autoimmune conditions. The CARAMEL trial with CNTY-101 is intended to commence in mid-2025, pending clinical trial application (CTA) approval.
Additional Clinical Development
In addition to the CARAMEL trial, Century Therapeutics plans to expand its ongoing CALiPSO-1 clinical trial (NCT06255028) to include sites in select European countries. The company will provide updates on initial clinical data from the CALiPSO-1 trial once a clear patient enrollment cadence has been established.
