Cullinan Therapeutics Gets FDA And Australian Therapeutic Goods Administration Clearance To Initiate Its Global Phase 1b/2a Clinical Trial In Adults With Relapsing And Refractory ITP And Warm Autoimmune Hemolytic Anemia

Global regulatory clearances in the U.S. and Australia support initiation of a Phase 1b/2a study in relapsing and refractory ITP and wAIHA

Study expands immunology portfolio into autoimmune cytopenias, evaluating a short-duration subcutaneous regimen designed to deplete antibody-producing plasma cells

CAMBRIDGE, Mass., Oct. 27, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration and Australian Therapeutic Goods Administration have granted clearance to initiate its global Phase 1b/2a clinical trial in adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA). The open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of subcutaneously administered velinotamig, a BCMAxCD3 T cell engager.