Trial Profile

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 18 Dec 2025

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At a glance

Drugs Gamgertamig (Primary)
Indications Autoimmune haemolytic anaemia; Cytopenia; Idiopathic thrombocytopenic purpura
Focus Adverse reactions
Acronyms Basket study
Sponsors Ouro Medicines

08 Dec 2025 According to Ouro Medicines media release, dosing now complete for the first cohort in this study and enrollment actively ongoing in the second cohort, and also company continue to expect results from this study in 2026.
08 Dec 2025 According to Ouro Medicines media release, gamgertamig (OM336) has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for development in the treatment of immune thrombocytopenia (ITP).
30 Sep 2025 Status changed from not yet recruiting to recruiting.

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