OM336 in Autoimmune Cytopenias

Not Applicable

Not yet recruiting

• Conditions: AIHA - Warm Autoimmune Hemolytic Anemia; ITP - Immune Thrombocytopenia; AIHA - Cold Autoimmune Hemolytic Anemia
• Interventions: Drug: OM336

• Registration Number: NCT07083960
• Lead Sponsor: Ouro Medicines

Brief Summary

An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.

Detailed Description

An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-08-01
• Primary Completion: 2026-12
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Active autoimmune cytopenia
• Relapsed/refractory after ≥1 prior treatment
• Body weight ≥ 55 kg
• Willing to comply with and study requirements and procedures

Key

Exclusion Criteria

• Previous treatment with a BCMA-targeted therapy
• Clinically significant infection within 3 months of screening
• Major surgery or splenectomy within 3 months of screening or planned during the study
• Pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
OM336 Dose Escalation	OM336	Participants will receive OM336 via subcutaneous injection in ascending dose cohorts

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	12 weeks	Incidence and severity of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	52 weeks	Incidence and severity of treatment-emergent adverse events (TEAEs)
To assess the pharmacokinetics (PK) of OM336	12 weeks	Serum concentrations of OM336
Detection of anti-drug antibodies	12 weeks	Detection of anti-drug antibodies