Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-06 @ 9:38 PM
Study NCT ID:
NCT02290951
Status:
COMPLETED
Last Update Posted:
2025-10-10
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-11', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety/overall frequency of adverse events (AEs)', 'timeFrame': 'Up to 24 months', 'description': 'Part A and B'}, {'measure': 'Safety/dose limiting toxicities (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'Part A and B'}, {'measure': 'Antitumor activity as measured by the objective response rate (ORR)', 'timeFrame': 'Through study completion, an average of 24 months', 'description': 'Expansion Cohorts:\n\n• Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy\n\nPart A'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (Concentration of odronextamab)', 'timeFrame': 'Up to 10 months', 'description': 'Peak plasma concentration (Cmax) of odronextamab\n\nPart A and B'}, {'measure': 'Incidence of anti-drug antibodies (ADA) to odronextamab', 'timeFrame': 'Over time; up to approximately 15 months', 'description': 'Part A and B'}, {'measure': 'Titer of ADA to odronextamab', 'timeFrame': 'Over time; up to approximately 15 months', 'description': 'Part A and B'}, {'measure': 'Incidence of neutralizing antibodies (NAb) to odronextamab over time', 'timeFrame': 'Over time; Up to approximately 15 months', 'description': 'Part A and B'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Through study completion, an average of 24 months', 'description': 'For dose escalation portion and expansion cohorts:\n\n* Aggressive lymphoma expansion cohort 2\n* FL grade 1-3a expansion cohorts 1 and 2 (Part A)\n\nFor dose escalation and dose expansion cohorts:\n\n* FL grade 1-3a\n* DLBCL\n* DLBCL post CAR T failure (Part B)'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 48 months', 'description': 'Part A and B'}, {'measure': 'Overall Survival', 'timeFrame': 'Until death or lost to follow-up/ withdrawal, approximately up to 48 months', 'description': 'Part A and B'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Until progression, approximately up to 48 months', 'description': 'Part A and B'}, {'measure': 'Minimal residual disease (MRD) for patients with CLL', 'timeFrame': 'Up to 24 months', 'description': 'Part A'}, {'measure': 'Duration of Complete Response (DOCR)', 'timeFrame': 'Until progression, approximately up to 48 months', 'description': 'Part B'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diffuse large B-cell lymphoma (DLBCL)', 'Follicular lymphoma (FL)', 'Aggressive lymphoma'], 'conditions': ['Non-Hodgkin Lymphoma', 'Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '39786390', 'type': 'DERIVED', 'citation': "Topp MS, Matasar M, Allan JN, Ansell SM, Barnes JA, Arnason JE, Michot JM, Goldschmidt N, O'Brien SM, Abadi U, Avivi I, Cheng Y, Flink DM, Zhu M, Brouwer-Visser J, Chaudhry A, Mohamed H, Ambati S, Crombie JL. Odronextamab monotherapy in R/R DLBCL after progression with CAR T-cell therapy: primary analysis of the ELM-1 study. Blood. 2025 Apr 3;145(14):1498-1509. doi: 10.1182/blood.2024027044."}, {'pmid': '35366963', 'type': 'DERIVED', 'citation': "Bannerji R, Arnason JE, Advani RH, Brown JR, Allan JN, Ansell SM, Barnes JA, O'Brien SM, Chavez JC, Duell J, Rosenwald A, Crombie JL, Ufkin M, Li J, Zhu M, Ambati SR, Chaudhry A, Lowy I, Topp MS. Odronextamab, a human CD20xCD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial. Lancet Haematol. 2022 May;9(5):e327-e339. doi: 10.1016/S2352-3026(22)00072-2. Epub 2022 Apr 1."}, {'pmid': '34997701', 'type': 'DERIVED', 'citation': 'Zhu M, Olson K, Kirshner JR, Khaksar Toroghi M, Yan H, Haber L, Meagher C, Flink DM, Ambati SR, Davis JD, DiCioccio AT, Smith EJ, Retter MW. Translational findings for odronextamab: From preclinical research to a first-in-human study in patients with CD20+ B-cell malignancies. Clin Transl Sci. 2022 Apr;15(4):954-966. doi: 10.1111/cts.13212. Epub 2022 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:\n\n * Part A (IV administration) B-NHL confirmed by National Cancer Institute (NCI) working group criteria\n * Part B (SC administration): Confirmed diagnosis of B-NHL requiring therapy as defined by WHO classification 2017\n2. Patients with B-NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL (Part A only) are not required to have received prior treatment with an anti-CD20 antibody therapy as defined in the protocol.\n\n * For the inclusion in the disease-specific expansion cohort enrolling DLBCL patients after failure of CAR-T therapy, the patient must have recovered from the toxicities of the lymphodepletion therapy and CAR-T infusion.\n * For inclusion in Part B, patients must have FL grade 1-3a or DLBCL (with or without prior CAR-T) per the criteria above, and:\n * Patients with FL grade 1-3a and DLBCL must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent\n3. All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan, if CT scan is not feasible.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n5. Life expectancy of at least 6 months\n6. Adequate bone marrow function as described in the protocol\n7. Adequate organ function as described in the protocol\n8. Willingness to undergo mandatory tumor biopsy pretreatment, if in the opinion of the investigator, the patient has an accessible lesion that can be biopsied without significant risk to the patient.\n9. Willing and able to comply with clinic visits and study-related procedures\n10. Provide signed informed consent or legally acceptable representative\n\nKey Exclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL\n2. History of or current relevant CNS pathology such as\n\n * Epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or\n * Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI\n3. Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug\n4. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection \\[(as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)\\].\n\n 1. Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection.\n 2. Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility.\n5. Patients who have received a live vaccination within 28 days of first dose of study treatment\n\nNote: Other protocol Inclusion/Exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02290951', 'acronym': 'ELM-1', 'briefTitle': 'Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)', 'orgStudyIdInfo': {'id': 'R1979-HM-1333'}, 'secondaryIdInfos': [{'id': '2015-004491-30', 'type': 'EUDRACT_NUMBER'}, {'id': '2024-514938-20-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'DLBCL post CAR-T', 'interventionNames': ['Drug: Odronextamab multiple dose levels']}, {'type': 'EXPERIMENTAL', 'label': '1N Part B', 'description': 'FL', 'interventionNames': ['Drug: Odronextamab multiple dose levels']}, {'type': 'EXPERIMENTAL', 'label': '2N Part B', 'description': 'DLBCL', 'interventionNames': ['Drug: Odronextamab multiple dose levels']}], 'interventions': [{'name': 'Odronextamab multiple dose levels', 'type': 'DRUG', 'otherNames': ['REGN1979'], 'description': 'Administered by intravenous (IV) infusion', 'armGroupLabels': ['Part A']}, {'name': 'Odronextamab multiple dose levels', 'type': 'DRUG', 'otherNames': ['REGN1979'], 'description': 'Administered by subcutaneous (SC) injection', 'armGroupLabels': ['1N Part B', '2N Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '76038', 'city': 'Rouen', 'state': 'Haute-Normandie', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '69495', 'city': 'Lyon', 'country': 'France', 'facility': 'CHU Hôpital Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitatsklinikum Wurzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '44281', 'city': 'Kfar Saba', 'state': 'Central District', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '5265601', 'city': 'Tel-Hashomer', 'state': 'Central District', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center'}, {'zip': '9112001', 'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '7747629', 'city': 'Ashdod', 'state': 'Southern District', 'country': 'Israel', 'facility': 'Assuta Ashdod University Hospital', 'geoPoint': {'lat': 31.79213, 'lon': 34.64966}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus - Hematology and Bone Marrow Transplantation Institute', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '3436212', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Lady Davis Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': 'tr1 3lq', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospitals NHS Trust', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}