Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-29 @ 1:30 PM
Study NCT ID:
NCT06331832
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-03-26
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Non-Hodgkin Lymphomas']}, 'descriptionModule': {'briefSummary': 'Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Demonstrated clinical benefit (SD, PR, or CR) on clinical trial protocol IGM-2323-001\n* There is no adequate alternative treatment available for the patient.\n* Provided consent to continue treatment on expanded access program.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to the first dose.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive measures.\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive.\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to mAb (or recombinant antibody related fusion proteins).\n* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of investigational product, or indicating patient would unlikely have potential benefit.\n* Pregnant, breastfeeding, or intending to become pregnant during the program or within 2 months after the final dose of imvotamab.\n* In the treating physician's judgement, the patient is unlikely to complete all procedures, including follow-up visits, or comply with the requirements for participation.\n* Vaccination with live virus vaccines during treatment and for 3 months following the last cycle of Imvotamab."}, 'identificationModule': {'nctId': 'NCT06331832', 'briefTitle': 'Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL', 'organization': {'class': 'INDUSTRY', 'fullName': 'IGM Biosciences, Inc.'}, 'officialTitle': 'Treatment Guidelines for Expanded Access of Imvotamab (IGM-2323) in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas From IGM-2323-001', 'orgStudyIdInfo': {'id': '2323-EAP'}, 'secondaryIdInfos': [{'id': '2021-002339-44', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'IGM2323', 'type': 'BIOLOGICAL', 'description': 'Imvotamab is a recombinant monoclonal antibody of the IgM kappa isotype that targets the human CD20 antigen. Its component J-chain is fused to a single chain Fv antibody fragment which targets human CD3ε.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Seoul', 'state': 'Gangnam-gu', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'START-Madrid Centro Integral Oncologico Clara Campal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IGM Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}