OM336 in Autoimmune Cytopenias | NCT07083960

Studies
OM336 in Autoimmune Cytopenias

NCT07083960

Sponsor

Ouro Medicines

Status

Recruiting

Last Update Posted

Sep 30, 2025Actual

Enrollment

32Estimated

Phase

Phase 1

Conditions

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

Interventions

OM336

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Jul 9, 2025

First Submission Date that Met QC Criteria

Jul 17, 2025

First Posted Date

Jul 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2025

Last Update Posted Date

Sep 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OM336 Dose Escalation	Experimental	Participants will receive OM336 via subcutaneous injection in ascending dose cohorts	Drug: OM336

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OM336	Drug	OM336 is an engineered bispecific antibody directed against BCMA and CD3	OM336 Dose Escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability	Incidence and severity of treatment emergent adverse events (TEAEs)	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety and Tolerability	Incidence and severity of treatment-emergent adverse events (TEAEs)	52 weeks
To assess the pharmacokinetics (PK) of OM336	Serum concentrations of OM336

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Sponsor	Contact	415-429-4887		info@ouromeds.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Canberra Hospital	Recruiting	Canberra	Australian Capital Territory	2605	Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000744	Anemia, Hemolytic, Autoimmune
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided