EMA approves OT-C001 trial in DLBCL

BY: Phillip McLeod

The European Medicines Agency (EMA) has approved an Investigational Medicinal Product Dossier (IMPD) for OT-C001, an allogeneic natural killer-cell therapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

This approval, announced on April 22, 2025, allows Emercell, a subsidiary of Onward Therapeutics, to initiate a phase 1 clinical trial combining OT-C001 with rituximab.

OT-C001 is derived from umbilical cord blood and administered to target DLBCL, according to the press release. The phase 1 study will test OT-C001 alongside rituximab, an anti-CD20 monoclonal antibody, to determine its safety and early effectiveness for patients who have not responded to standard therapies.

This study will enroll patients at various European centers to explore OT-C001’s benefits, according to the company.