Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 12:43 PM
Study NCT ID:
NCT05601466
Status:
TERMINATED
Last Update Posted:
2024-11-06
First Post:
2022-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'It did not reach the expected results of clinical trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '28 Days from first dose of QN-023a'}, {'measure': 'The incidence of subjects with Dose Limiting Toxicities within each dose level cohort', 'timeFrame': '28 Days from first dose of QN-023a'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate(ORR)', 'timeFrame': 'Up to approximately 2 years after last dose of QN-023a'}, {'measure': 'Relapse-free survival (RFS) of participants', 'timeFrame': 'Up to approximately 2 years after last dose of QN-023a'}, {'measure': 'Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood', 'timeFrame': 'Up to approximately 2 years after last dose of QN-023a', 'description': 'The PK of QN-023a in peripheral blood will be reported as the relative percentage of product (QN-023a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AML, Adult']}, 'descriptionModule': {'briefSummary': 'This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).\n\nThe clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Provision of signed and dated informed consent form (ICF)\n* ≥18 years old\n* Diagnosis of r/r AML\n* Subjects with CD33 positive leukemia cells\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n* Adequate organ function as defined in the protocol\n* Donor specific antibody (DSA) to QN-023a: MFI \\<= 2000\n\nKey Exclusion Criteria:\n\n* Allergic to drug used in this study\n* Accept other anti-tumor drug within certain time of day 0 (first QN-023a dose infusion), time window and drug defined in the protocol.\n* received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy\n* Acute Promyelocytic Leukemia (APL)\n* Active central nervous system Leukemia.\n* Uncontrolled, active clinically significant infection\n* Clinically significant cardiovascular disease as defined in the protocol\n* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection\n* History of central nervous system (CNS) disease such as stroke, epilepsy.\n* Females are pregnant or lactating\n* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject'}, 'identificationModule': {'nctId': 'NCT05601466', 'briefTitle': 'Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Clinical Study on QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'IIT2022029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QN-023a', 'description': 'QN-023a in adult subjects with r/r AML', 'interventionNames': ['Drug: QN-023a', 'Drug: Cyclophosphamid', 'Drug: Fludarabine', 'Drug: Cytarabine']}], 'interventions': [{'name': 'QN-023a', 'type': 'DRUG', 'description': 'NK cell therapy', 'armGroupLabels': ['QN-023a']}, {'name': 'Cyclophosphamid', 'type': 'DRUG', 'description': 'Lympho-conditioning Agent', 'armGroupLabels': ['QN-023a']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Lympho-conditioning Agent', 'armGroupLabels': ['QN-023a']}, {'name': 'Cytarabine', 'type': 'DRUG', 'description': 'Lympho-conditioning Agent', 'armGroupLabels': ['QN-023a']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Institute of Hematology & Blood Diseases Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hangzhou Qihan Biotech Co.,Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}