Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-01 @ 4:49 PM
Study NCT ID:
NCT07018050
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
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': 'C467566', 'term': 'pomalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C556306', 'term': 'daratumumab'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], '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'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR (Partial Response [PR] or Better)', 'timeFrame': 'Up to 2 years', 'description': 'Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria'}, {'measure': 'Overall Minimal Residual Disease (MRD)', 'timeFrame': 'Up to 2 years', 'description': 'MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10\\^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;\n* Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;\n* Measurable disease at screening, defined by at least one of the following:\n\n * Serum M-protein ≥1.0 g/dL (10 g/L);\n * Urine M-protein ≥200 mg/24 hours;\n * Serum immunoglobulin free light chain ≥10 mg/dL (100 mg/L) with an abnormal serum immunoglobulin κ/λ free light chain ratio.\n\nExclusion Criteria:\n\n* History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);\n* Prior anti-myeloma therapies within the specified timeframes before enrollment:\n\n * Previous treatment with GPRC5D-targeted therapy;\n * Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T\\], natural killer \\[NK\\] cell therapy) within 3 months;\n * Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer);\n * Monoclonal antibodies or bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer);\n * Cytotoxic therapy within 21 days;\n * Proteasome inhibitor therapy within 14 days;\n * Immunomodulatory drug therapy within 7 days;\n* Radiotherapy within 14 days (except low-dose palliative radiation \\[10-30 Gy\\]);\n* Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);\n* Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);\n* Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);\n* Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).'}, 'identificationModule': {'nctId': 'NCT07018050', 'briefTitle': 'Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma', 'orgStudyIdInfo': {'id': 'QLS32015-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS32015(SC) in combination with Pomalidomide', 'description': 'Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.', 'interventionNames': ['Drug: QLS32015', 'Drug: Pomalidomide', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'QLS32015(SC) in combination with QL2109 or Daratumumab.', 'description': 'Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.', 'interventionNames': ['Drug: QLS32015', 'Drug: Dexamethasone', 'Drug: QL2109 or Daratumumab']}, {'type': 'EXPERIMENTAL', 'label': 'QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide', 'description': 'Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug', 'interventionNames': ['Drug: QLS32015', 'Drug: Pomalidomide', 'Drug: Dexamethasone', 'Drug: QL2109 or Daratumumab']}, {'type': 'EXPERIMENTAL', 'label': 'QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide', 'description': 'Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug', 'interventionNames': ['Drug: QLS32015', 'Drug: Dexamethasone', 'Drug: Bortezomib', 'Drug: Lenalidomide']}], 'interventions': [{'name': 'QLS32015', 'type': 'DRUG', 'description': 'QLS32015 will be administered subcutaneously', 'armGroupLabels': ['QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide', 'QLS32015(SC) in combination with Pomalidomide', 'QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide', 'QLS32015(SC) in combination with QL2109 or Daratumumab.']}, {'name': 'Pomalidomide', 'type': 'DRUG', 'description': 'Pomalidomide will be self-administered as a single dose orally', 'armGroupLabels': ['QLS32015(SC) in combination with Pomalidomide', 'QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone will be administered orally or intravenously', 'armGroupLabels': ['QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide', 'QLS32015(SC) in combination with Pomalidomide', 'QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide', 'QLS32015(SC) in combination with QL2109 or Daratumumab.']}, {'name': 'QL2109 or Daratumumab', 'type': 'DRUG', 'description': 'QL2109 or Daratumumab will be administered subcutaneously.', 'armGroupLabels': ['QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide', 'QLS32015(SC) in combination with QL2109 or Daratumumab.']}, {'name': 'Bortezomib', 'type': 'DRUG', 'description': 'Bortezomib will be administered subcutaneously', 'armGroupLabels': ['QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Lenalidomide will be self-administered as a single dose orally', 'armGroupLabels': ['QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang An', 'role': 'CONTACT', 'email': 'angang@ihcams.ac.cn', 'phone': '008613502181109'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Gang An, Professor', 'role': 'CONTACT', 'email': 'angang@ihcams.ac.cn', 'phone': '008613502181109'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}