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Cullinan Therapeutics has received IND clearance from the US FDA & clearance from Australia’s TGA to initiate a global P-Ib/IIa trial of velinotamig (CLN-803), a SC BCMAxCD3 T-cell engager, in adults with R/R immune thrombocytopenia (ITP) & warm autoimmune hemolytic anemia (wAIHA)
The open-label, multicenter trial (NCT07738822) will evaluate a defined course of 4 SC doses, with Part A (P-Ib dose escalation) & Part B (P-IIa dose expansion in separate ITP & wAIHA groups), assessing safety, tolerability & disease activity
Cullinan holds global (ex-Greater China) rights to velinotamig from Genrix Bio, which will present autoimmune data at ACR Convergence 2026 on Nov 8, 2026
Ref: GlobeNewswire | Image: Cullinan Therapeutics | Press Release
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The post Cullinan Therapeutics Receives the US FDA’s IND Clearance for Velinotamig to Treat ITP and wAIHA appeared first on PharmaShots.