OM336 in Autoimmune Cytopenias

NCT ID: NCT07083960

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-09-30

Brief Summary

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

Detailed Description

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

Conditions

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AIHA - Warm Autoimmune Hemolytic Anemia AIHA - Cold Autoimmune Hemolytic Anemia ITP - Immune Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OM336 Dose Escalation

Participants will receive OM336 via subcutaneous injection in ascending dose cohorts

Group Type EXPERIMENTAL

OM336

Intervention Type DRUG

OM336 is an engineered bispecific antibody directed against BCMA and CD3

Interventions

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OM336

OM336 is an engineered bispecific antibody directed against BCMA and CD3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ouro Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Canberra Hospital

Canberra, Australian Capital Territory, Australia

Site Status RECRUITING

Liverpool Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Icon Cancer Center South Brisbane

Brisbane, Queensland, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Study Sponsor

Role: CONTACT

415-429-4887

Facility Contacts

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Clinical Research Coordinator

Role: primary

+61 2 5124 4338

Clinical Research Coordinator

Role: primary

+61 474 279 274

Clinical Research Coordinator

Role: primary

+61 7 3737 4795

Other Identifiers

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OM336-AIC-1001

Identifier Type: -

Identifier Source: org_study_id

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