Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 1:20 PM
Study NCT ID:
NCT07083960
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OM336 in Autoimmune Cytopenias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000744', 'term': 'Anemia, Hemolytic, Autoimmune'}, {'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '12 weeks', 'description': 'Incidence and severity of treatment emergent adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '52 weeks', 'description': 'Incidence and severity of treatment-emergent adverse events (TEAEs)'}, {'measure': 'To assess the pharmacokinetics (PK) of OM336', 'timeFrame': '12 weeks', 'description': 'Serum concentrations of OM336'}, {'measure': 'Detection of anti-drug antibodies', 'timeFrame': '12 weeks', 'description': 'Detection of anti-drug antibodies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AIHA - Warm Autoimmune Hemolytic Anemia', 'AIHA - Cold Autoimmune Hemolytic Anemia', 'ITP - Immune Thrombocytopenia']}, 'descriptionModule': {'briefSummary': 'An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.', 'detailedDescription': 'An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Active autoimmune cytopenia\n* Relapsed/refractory after ≥1 prior treatment\n* Body weight ≥ 55 kg\n* Willing to comply with and study requirements and procedures\n\nKey Exclusion Criteria:\n\n* Previous treatment with a BCMA-targeted therapy\n* Clinically significant infection within 3 months of screening\n* Major surgery or splenectomy within 3 months of screening or planned during the study\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07083960', 'briefTitle': 'OM336 in Autoimmune Cytopenias', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ouro Medicines'}, 'officialTitle': 'An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias', 'orgStudyIdInfo': {'id': 'OM336-AIC-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OM336 Dose Escalation', 'description': 'Participants will receive OM336 via subcutaneous injection in ascending dose cohorts', 'interventionNames': ['Drug: OM336']}], 'interventions': [{'name': 'OM336', 'type': 'DRUG', 'description': 'OM336 is an engineered bispecific antibody directed against BCMA and CD3', 'armGroupLabels': ['OM336 Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Canberra', 'state': 'Australian Capital Territory', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'Ryshelle.kilby@act.gov.au', 'phone': '+61 2 5124 4338'}], 'facility': 'The Canberra Hospital', 'geoPoint': {'lat': -35.28346, 'lon': 149.12807}}, {'zip': '2107', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'pinky.patel@health.nsw.gov.au', 'phone': '+61 474 279 274'}], 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4066', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'Annabelle.morton@icon.team', 'phone': '+61 7 3737 4795'}], 'facility': 'Icon Cancer Center South Brisbane', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'centralContacts': [{'name': 'Study Sponsor', 'role': 'CONTACT', 'email': 'info@ouromeds.com', 'phone': '415-429-4887'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ouro Medicines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}