Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-22 @ 4:14 PM
Study NCT ID:
NCT04887259
Status:
TERMINATED
Last Update Posted:
2025-01-27
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System 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': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'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': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'The decision to discontinue LAVA-051clinical trial follows a recent review of the competitive landscape that has continued to evolve (Business decision). The decision is not due to safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-10', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 & Part 2 - Frequency and severity of AEs:', 'timeFrame': 'Approximately 6 months', 'description': 'Frequency, severity, and grading of Adverse Events using the Common Terminology Criteria and grading for Adverse Events (CTCAE) v5.0. CRS will be evaluated using the ASTCT.'}, {'measure': 'Part 1 - Frequency and type of DLT', 'timeFrame': 'First 28 days of treatment', 'description': 'A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment. These events will be classified according to the CTCAE v5.0; CRS will be evaluated according to the ASTCT consensus criteria'}], 'secondaryOutcomes': [{'measure': 'Part 1 & Part 2: Number of participants with an antitumor response', 'timeFrame': 'Approximately 6 months', 'description': 'Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria'}, {'measure': 'Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Approximately 6 months', 'description': 'Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051'}, {'measure': 'Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies', 'timeFrame': 'Approximately 6 months', 'description': 'Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLL', 'Phase 1 dose escalation', 'Phase 1 safety', 'Open label', 'MM', 'AML', 'relapsed', 'refractory'], 'conditions': ['Chronic Lymphocytic Leukemia', 'Multiple Myeloma', 'Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A phase 1, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).', 'detailedDescription': 'An open-label, phase 1 dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051 in patients with relapsed or refractory CLL, MM, or AML.\n\nThe trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "KEY INCLUSION CRITERIA\n\n1. Patient must be 18 years of age inclusive or above at the time of signing the informed consent.\n2. Patients with documented diagnosis of relapsed or refractory CLL, MM, or AML who have failed to respond to or who have relapsed after prior therapy and are not amenable to standard treatments or for whom no standard treatments are available.\n3. Predicated life expectancy of ≥ 3 months.\n4. ECOG performance status of 0 or 1.\n5. Males or non-pregnant, non-breastfeeding females who are either:\n\n 1. Surgically sterile.\n 2. Female of childbearing potential with a negative pregnancy test and compliant with an effective contraceptive regimen.\n 3. Female, postmenopausal.\n 4. Male compliant with an effective contraceptive regimen.\n 5. Male refraining from donating sperm.\n6. Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures.\n\nKEY EXCLUSION CRITERIA\n\n1. Prior allogeneic bone marrow transplant if the patient still has active acute or chronic graft versus host disease requiring \\>10 mg prednisone or equivalent corticosteroids.\n2. Concomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma. Patients who had no evidence of disease from another primary cancer for 2 or more years are allowed to participate in the trial. Localized non-metastatic prostate cancer, not requiring systemic treatment, and for which no local treatment is planned, is allowed.\n3. Uncontrolled or severe intercurrent medical condition.\n4. Previous treatment with an aminobisphonsphonate IV (e.g. ibandronate, pamidronate, zoledronate) within 4 weeks prior to initial IMP administration.\n5. Known ongoing drug or alcohol abuse in the opinion of the investigator.\n6. Previous autologous haematopoietic stem cell transplantation (HSCT) or treatment with Chimeric Antigen Receptor (CAR) T-cell therapy within 6 months prior to initial IMP administration.\n7. Immunodeficiency disorders.\n8. Patients with Richter's transformation are excluded.\n\nOther eligibility criteria will apply during full screening."}, 'identificationModule': {'nctId': 'NCT04887259', 'briefTitle': 'Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lava Therapeutics'}, 'officialTitle': 'A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of LAVA-051 in Patients with Relapsed or Refractory CLL, MM, or AML', 'orgStudyIdInfo': {'id': 'LV2020-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAVA-051', 'description': 'Part 1 (dose escalation): LAVA-051 will be given to patients via intravenous (IV) infusion with dose escalation. A selected group of patients will also receive a low dose of interleukin 2 via subcutaneous injection.\n\n* Group A: LAVA-051\n* Group B: LAVA-051 + low dose interleukin 2\n\nPart 2 (dose expansion): patients will receive LAVA-051 at the dose and regimen established in Part 1 of the study', 'interventionNames': ['Biological: LAVA-051', 'Biological: Interleukin 2']}], 'interventions': [{'name': 'LAVA-051', 'type': 'BIOLOGICAL', 'description': 'In part 1 and part 2, LAVA-051 will be administered via intravenous (IV) infusion', 'armGroupLabels': ['LAVA-051']}, {'name': 'Interleukin 2', 'type': 'BIOLOGICAL', 'description': 'In Part 1 and Part 2, a low dose of interleukin 2 will be given via subcutaneous injection with LAVA-051 in a selected group of patients', 'armGroupLabels': ['LAVA-051']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute, Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'University Hospital of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "University Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28027', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Cima University of Navarra', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clinica Universida de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'Clinical Trials Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lava Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lava Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}