Velinotamig

October 27, 2026: Cullinan Therapeutics (NASDAQ: CGEM) said the FDA and Australia’s Therapeutic Goods Administration cleared initiation of a global Phase 1b/2a trial of velinotamig (CLN-803/GR1803), a BCMAxCD3 T-cell engager, in adults with relapsing/refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).

The open-label, multicenter study (NCT07738822) will assess safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of a defined four-dose subcutaneous regimen. Part A is a multiple-ascending-dose Phase 1b portion; Part B is a Phase 2a dose-expansion in separate ITP and wAIHA cohorts. Primary objectives are safety, tolerability, and effect on disease activity.

The company said the program is intended to deplete BCMA-expressing, autoantibody-producing plasma cells in autoimmune cytopenias.

An additional upcoming catalyst is clinical data on velinotamig in autoimmune diseases to be presented by Genrix Bio at the American College of Rheumatology Convergence 2026 meeting on November 8, 2026. The release also says updated results are expected from an ongoing Phase 1b/2a study in refractory systemic lupus erythematosus in China.