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Recruiting NCT07083960

OM336 in Autoimmune Cytopenias

Phase I Interventional AIHA - Warm Autoimmune Hemolytic Anemia AIHA - Cold Autoimmune Hemolytic Anemia ITP - Immune Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OM336.
Who it may be relevant to
Registry conditions: AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias

Overview

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.

Interventions

  • Drug OM336
    OM336 is an engineered bispecific antibody directed against BCMA and CD3

Primary outcome measures

  • Safety and Tolerability [Time frame: 12 weeks]
Secondary outcome measures (3)
  • Safety and Tolerability [Time frame: 52 weeks]
  • To assess the pharmacokinetics (PK) of OM336 [Time frame: 12 weeks]
  • Detection of anti-drug antibodies [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • The Canberra Hospital — Canberra
  • Liverpool Hospital — Sydney
  • Icon Cancer Center South Brisbane — Brisbane

Identifiers

NCT: NCT07083960 · OM336-AIC-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗