FDA clears Cullinan's velinotamig trial for two autoimmune blood disorders
Editorial illustration — Press Pass USACullinan Therapeutics said Tuesday that U.S. and Australian regulators have cleared it to start a global early-stage trial of velinotamig, an experimental immune therapy, in two serious autoimmune blood disorders that destroy a patient's own platelets or red blood cells.
The open-label, multicenter Phase 1b/2a study will enroll adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA). It will test a short-duration regimen of velinotamig given under the skin, measuring safety, tolerability, pharmacokinetics, pharmacodynamics, immune response and preliminary clinical activity.
Velinotamig is a BCMAxCD3 T-cell engager designed to redirect the body's own T cells against BCMA-expressing cells, including the antibody-producing plasma cells that drive both diseases. In ITP, rogue autoantibodies destroy platelets, raising bleeding risk; in wAIHA, they destroy red blood cells, causing anemia. Patients in both conditions often face debilitating fatigue and reduced quality of life, and many remain dependent on chronic treatment or relapse despite available therapies.
The clearance to begin the trial is not an approval of the drug: velinotamig remains investigational, and no efficacy results in ITP or wAIHA have been reported. The company said the study expands its immunology portfolio into autoimmune cytopenias; it did not give a timeline for first results.
Sources: Cullinan Therapeutics via GlobeNewswire (Oct 27, 2026); Cullinan Therapeutics pipeline page.
Sponsored