Cullinan Oncology, Inc. Announces U.S. FDA Clearance of Investigational New Drug Application for CLN-978, Novel T-Cell Engager for Treatment of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Cullinan Oncology, Inc. announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-978, a CD19/CD3 T-cell engaging antibody construct with a human serum albumin (HSA) binding domain to increase serum half-life. Cullinan Oncology will initially evaluate CLN-978 in a Phase 1 trial for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). The study is a Phase 1, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and efficacy of CLN-978 in patients with relapsed/refractory B-NHL.

IND submission remains on track for CLN-617 (IL-2, IL-12 fusion protein) in the first half of 2023.