Cullinan Therapeutics Advances Velinotamig into Global Clinical Development for Autoimmune Cytopenias Following IND Clearance by the U.S. FDA
Cullinan Therapeutics received FDA and Australian TGA clearance to initiate a global Phase 1b/2a trial of velinotamig in adults with relapsing and refractory ITP and wAIHA. The open-label multicenter study, NCT07738822, evaluates a defined course of four subcutaneous doses of the BCMAxCD3 T cell engager, expanding Cullinan's immunology portfolio into autoimmune cytopenias. Cullinan holds an ex-Greater China, all-indication exclusive license from Genrix Bio, which is separately evaluating the drug in refractory SLE; emerging velinotamig data will be presented at ACR Convergence on November 8, 2026. The company cites a U.S.
Key figures
- Drug Name
- velinotamig (CLN-803, GR1803)
- Phase Of Trial
- Phase 1b/2a
- Regimen
- short-duration subcutaneous regimen of four doses
- Indication
- relapsing and refractory ITP and wAIHA
- Acr data date
- November 8, 2026
- Us itp prevalence
- approximately 62,000 adults
- Us waiha prevalence
- approximately 33,300 adults
AI analysis
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