Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03486067
Status:
TERMINATED
Last Update Posted:
2025-04-17
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'whyStopped': 'Business objectives have changed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'Up to approximately 63 months', 'description': 'Number of participants with Adverse Events'}, {'measure': 'Dose Limiting Toxicity (DLT)', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.'}, {'measure': 'Non-Tolerated Dose (NTD)', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.'}, {'measure': 'Time to Response', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).'}, {'measure': 'Duration of Response', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 60 months', 'description': 'Is defined as the time from the first dose of CC-93269 to death from any cause.'}, {'measure': 'Pharmacokinetics - Cmax', 'timeFrame': 'Up to 60 months', 'description': 'Maximum serum concentration of drug'}, {'measure': 'Pharmacokinetics - Cmin', 'timeFrame': 'Up to 60 months', 'description': 'Minimum serum concentration of drug'}, {'measure': 'Pharmacokinetics - AUC', 'timeFrame': 'Up to 60 months', 'description': 'Area under the curve'}, {'measure': 'Pharmacokinetics - tmax', 'timeFrame': 'Up to 60 months', 'description': 'Time to peak (maximum) serum concentration'}, {'measure': 'Pharmacokinetics - t1/2', 'timeFrame': 'Up to 60 months', 'description': 'Terminal Half-life'}, {'measure': 'Pharmacokinetics - CL', 'timeFrame': 'Up to 60 months', 'description': 'Apparent total body clearance'}, {'measure': 'Pharmacokinetics - Vss', 'timeFrame': 'Up to 60 months', 'description': 'Volume of distribution at steady-state'}, {'measure': 'Pharmacokinetics - accumulation index of alnuctamab', 'timeFrame': 'Up to 60 months', 'description': 'Accumulation ratio of drug'}, {'measure': 'Presence and frequency of anti-drug antibodies (ADA)', 'timeFrame': 'Up to 60 months', 'description': 'Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'BCMA X CD3 T Cell', 'Antibody', 'CC-93269', 'Relapsed and Refractory'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.', 'detailedDescription': 'The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of multiple myeloma with relapsed and refractory disease\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1\n* Must have measurable disease as determined by the central laboratory\n\nExclusion Criteria:\n\n* Symptomatic central nervous system involvement of multiple myeloma\n* Prior autologous stem cell transplant ≤ 3 months prior\n* Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior\n* History of concurrent second cancers requiring active, ongoing systemic treatment\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03486067', 'briefTitle': 'Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CC-93269-MM-001'}, 'secondaryIdInfos': [{'id': 'U1111-1210-6325', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '2023-506564-14', 'type': 'OTHER', 'domain': 'EU CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of CC-93269', 'interventionNames': ['Drug: CC-93269']}], 'interventions': [{'name': 'CC-93269', 'type': 'DRUG', 'otherNames': ['Alnuctamab'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of CC-93269']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 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