OM336 in Autoimmune Cytopenias

Ouro Medicines

Status and phase: Not yet enrolling; Phase 1

Conditions: AIHA - Warm Autoimmune Hemolytic Anemia; AIHA - Cold Autoimmune Hemolytic Anemia; ITP - Immune Thrombocytopenia

Treatments: Drug: OM336

Study type: Interventional

Funder types: Industry

Identifiers

NCT07083960

OM336-AIC-1001

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 1 patient group

OM336 Dose Escalation

Experimental group

Description:

Participants will receive OM336 via subcutaneous injection in ascending dose cohorts

Treatment:

Drug: OM336