Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-13 @ 5:53 PM
Study NCT ID:
NCT05647512
Status:
WITHDRAWN
Last Update Posted:
2023-11-18
First Post:
2022-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'According to sponsor strategy', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicity (DLT)', 'timeFrame': 'Cycle 1 of each cohort. Duration of one cycle is 21 days', 'description': 'DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period'}, {'measure': 'Adverse Events (AE) and Serious Adverse Events (SAE)', 'timeFrame': 'From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy', 'description': 'The safety profile of LM-305 will be assessed by monitoring the adverse events'}], 'secondaryOutcomes': [{'measure': 'Area under plasma concentration vs time curve (AUC) for LM-305', 'timeFrame': 'Up to finished cycle 5 (each cycle is 21 days)', 'description': 'changes in AUC over time in participants with LM-305'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory Multiple Myeloma', 'Other Plasma Cell Diseases']}, 'descriptionModule': {'briefSummary': 'A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)', 'detailedDescription': 'A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects will be enrolled into the study only if they meet all of the following inclusion criteria:\n\n1. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Aged ≥18 years old when sign the ICF, male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。\n4. Life expectancy ≥ 6 months.\n5. Subjects must show appropriate organ and marrow function in laboratory examinations\n\nExclusion Criteria:\n\nSubjects will be excluded from the study, if they meet any of the following criteria:\n\n1. A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing\n2. Subjects who have severe cardiovascular disease。\n3. Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP.\n4. Child-bearing potential female who have positive results in pregnancy test or are lactating.\n5. Subject who is judged as not eligible to participate in this study by the investigator.'}, 'identificationModule': {'nctId': 'NCT05647512', 'briefTitle': 'Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'LaNova Medicines Limited'}, 'officialTitle': 'A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases', 'orgStudyIdInfo': {'id': 'LM305-01-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LM-305 Dose Escalation', 'description': 'Administered intravenously', 'interventionNames': ['Drug: LM-305']}, {'type': 'EXPERIMENTAL', 'label': 'LM-305 Combination Expansion', 'description': 'LM-305 Administered intravenously Dexamethasone Orally', 'interventionNames': ['Drug: LM-305', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'LM-305', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['LM-305 Combination Expansion', 'LM-305 Dose Escalation']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LM-305 Combination Expansion']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Depei Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LaNova Medicines Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}