Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT04860466
Status:
TERMINATED
Last Update Posted:
2024-10-16
First Post:
2021-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 9}}, 'statusModule': {'whyStopped': 'Business objectives have changed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'From enrollment until at least 28 days after completion of study treatment', 'description': "An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE."}, {'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Up to approximately 18 months', 'description': 'Number of participants with a DLT'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'Up to approximately 18 months', 'description': 'Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 2 years after study treatment', 'description': 'Is defined as the percent of participants whose best response is CR or PR'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to 2 years after study treatment', 'description': 'Is defined as the time from the first dose of CC-96673 to tumor response'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 2 years after study treatment', 'description': 'Is defined as the time from tumor response to progression/death'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to 2 years after study treatment', 'description': 'Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause'}, {'measure': 'Pharmacokinetics - Cmax', 'timeFrame': 'Up to 24 Months', 'description': 'Maximum observed serum concentration of drug'}, {'measure': 'Pharmacokinetics - AUC', 'timeFrame': 'Up to 24 Months', 'description': 'Area under the serum concentration-time curve'}, {'measure': 'Pharmacokinetics - tmax', 'timeFrame': 'Up to 24 Months', 'description': 'Time of maximum observed serum concentration'}, {'measure': 'Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies', 'timeFrame': 'Up to 24 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsed or Refractory', "Non-Hodgkin's Lymphoma", 'CC-96673', 'Dose Finding'], 'conditions': ['Lymphoma, Non-Hodgkin']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': "The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).\n\nThe study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must satisfy the following criteria to be enrolled in the study:\n\n1. Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.\n3. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n4. Participant must have a history of NHL that has relapsed or progressed.\n5. Participant has an ECOG PS of 0 or 1.\n6. Participants must have acceptable laboratory values as specified in the protocol.\n\nExclusion Criteria:\n\n1. Participant has cancer with symptomatic central nervous system (CNS) involvement\n2. Participant is on chronic systemic immunosuppressive therapy or corticosteroids or subjects with clinically significant graft-versus-host disease (GVHD). Intranasal, inhaled, topical, or local corticosteroid injections, or steroids as premedication for hypersensitivity reactions are exceptions to this criterion.\n3. Inadequate cardiac function or significant cardiovascular disease\n4. Participant has received prior investigational therapy directed at CD47 or SIRPα.\n5. Participant had major surgery ≤ 2 weeks prior to starting CC-96673.\n6. Participant is a pregnant or lactating female or intends to become pregnant during participation of the study.\n7. Participant has known active human immunodeficiency virus (HIV) infection.\n8. Participant has active hepatitis B or C (HBV/HCV) infection.\n9. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.\n10. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.\n11. History of concurrent second cancers requiring active, ongoing systemic treatment.\n12. Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.\n13. Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT04860466', 'briefTitle': "A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': "A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'CC-96673-NHL-001'}, 'secondaryIdInfos': [{'id': '2020-004631-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of CC-96673', 'description': 'CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule', 'interventionNames': ['Drug: CC-96673']}], 'interventions': [{'name': 'CC-96673', 'type': 'DRUG', 'description': 'IV Infusion', 'armGroupLabels': ['Administration of CC-96673']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Local Institution - 104', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68198-6840', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Local Institution - 103', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 101', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98124', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Local Institution - 102', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution - 201', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution - 202', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Local Institution - UNK-5', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Local Institution - 303', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Local Institution - 302', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hopital Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '28027', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution - 401', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Local Institution - 403', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Local Institution - 402', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'See Plan Description', 'ipdSharing': 'YES', 'description': 'Information relating to our policy on data sharing and the process for requesting data can be found at the following link:\n\nhttps://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/', 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}