Cullinan Therapeutics Advances Velinotamig into Global Clinical Development for Autoimmune Cytopenias Following IND Clearance by the U.S. FDA
Globe Newswire•27/10/2026•07:00 ET
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Key Highlights
- ➤Cullinan Therapeutics (CGEM) receives U.S. and Australian clearance for velinotamig trial
- ➤Phase 1b/2a study will enroll adults with relapsing, refractory ITP or wAIHA
- ➤Study evaluates four subcutaneous doses of BCMAxCD3 T cell engager
- ➤Global trial expands Cullinan’s immunology portfolio into autoimmune cytopenias
- ➤Genrix Bio will present velinotamig autoimmune-disease data November 8, 2026
Expert Statements
Jeffrey Jones, Chief Medical Officer of Cullinan Therapeutics
“Our autoimmune portfolio is built around complementary T cell engagers targeting CD19 and BCMA, a strategic approach designed to address distinct immune cell populations that drive disease across a spectrum of autoimmune conditions.”
Jeffrey Jones, Chief Medical Officer of Cullinan Therapeutics
“ITP and wAIHA are compelling settings for which targeting antibody-producing plasma cells with a defined course of velinotamig may deliver durable clinical benefit.”
Jeffrey Jones, Chief Medical Officer of Cullinan Therapeutics
“Emerging clinical data with BCMA-directed therapies have provided proof of concept for this mechanism in autoimmune cytopenias, including in some patients whose disease persisted despite prior treatment with CAR T therapy.”
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
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