Recruiting
Phase 1

OM336

Sponsor:

Lakefront Biotherapeutics West LLC

Code:

NCT07083960

Conditions

AIHA - Warm Autoimmune Hemolytic Anemia

AIHA - Cold Autoimmune Hemolytic Anemia

ITP - Immune Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

OM336

Study Details

Brief summary:

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

Conditions

AIHA - Warm Autoimmune Hemolytic Anemia

AIHA - Cold Autoimmune Hemolytic Anemia

ITP - Immune Thrombocytopenia

Study ID

NCT07083960

Start date

Aug 1, 2025

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OM336 Dose Escalation

Participants will receive OM336 via subcutaneous injection in ascending dose cohorts

Interventions

OM336

OM336 is an engineered bispecific antibody directed against BCMA and CD3

Primary outcome measure

  • Safety and Tolerability [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Study Sponsor

415-429-4887clinicaltrials@lakefrontbio.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Primary Contact

(888) 734-0917shhussain@coh.org

Medstar

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Primary Contact

202-444-2000jacobsh@georgetown.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Primary Contact

734-764-1817jreginal@med.umich.edu

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Primary Contact

855-557-0555Milleris@fredhutch.org

More Information

Sponsor

Lakefront Biotherapeutics West LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lakefront Biotherapeutics West LLC on 2026-09-03.