Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05990920
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2023-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs', 'timeFrame': '4 weeks', 'description': 'Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs'}, {'measure': 'MTD and/or RP2D', 'timeFrame': '8 weeks', 'description': 'Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': '12 weeks', 'description': 'Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pathologically Confirmed Cancer Refractory to Conventional Therapy', 'Refractory Cancer', 'Metastatic Cancer', 'Recurrent Cancer', 'Solid Tumor, Adult', 'Solid Tumor', 'Advanced Cancer', 'Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test SNK02 in participants with pathologically confirmed cancer that is refractory to conventional therapy. The main questions it aims to answer are:\n\n* Is SNK02 safety and tolerable when administered weekly as an intravenous infusion\n* What is the maximum dose that is tolerated of SNK02 Participants will be administered SNK02 weekly for 8 weeks and undergo medical evaluation to provide initial clinical safety data for the treatment of cancer with allogeneic NK cells as a monotherapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of refractory cancer that has failed at least prior line of conventional standard of care therapy.\n* Diagnosed with any histologically confirmed malignancy whose disease is confirmed to be metastatic and/or unresectable for which standard curative or beneficial treatments are no longer effective.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* ≥ 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational).\n* ≥ 2 weeks since prior palliative radiotherapy.\n* Complete recovery to baseline or Grade 1 NCI CTCAE v5.0 from AE of prior surgery, radiotherapy, endocrine therapy, and other therapy as applicable, with exception of grade 2 alopecia from prior chemotherapy.\n* Adequate bone marrow function:\n\n * Neutrophils: ≥ 1.5 K/µL without colony-stimulating factor support\n * Platelet Count: ≥ 100 K/µL\n * Hemoglobin: ≥ 9.0 g/dL without need for hematopoietic growth factor or transfusion support\n * No ongoing transfusion requirements\n* Adequate hepatic function:\n\n * Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), does not apply to patients with Gilbert\'s syndrome\n * Serum albumin ≥ 3.0 g/dL\n * ALT and AST ≤ 2.5 × ULN, unless hepatic metastases are present then \\< 5 x ULN\n* Adequate renal function with creatinine ≤ 2.0 mg/dL.\n* Coagulation: INR or aPTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.\n* Adequate pulmonary function as assessed by pulse oximetry (\\>92% oxygen saturation on room air).\n* Negative pregnancy test for women of childbearing potential (i.e., all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization) and agree to use of effective contraception (hormonal or barrier method of birth control) during study.\n* Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n\nExclusion Criteria:\n\n* Pregnant and/or lactating females.\n* Life expectancy of less than three months.\n* Currently being treated by "biological therapy" as defined by the National Cancer Institute (https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet) Examples include checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, CAR-T therapy, and natural killer (NK) cell therapy.\n* Participants that are actively positive for COVID.\n* Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy, with exception to the following:\n\n * intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);\n * Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;\n * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n* Prior clinical trial requiring participant to receive an investigational drug within four weeks of enrollment.\n* Live vaccine within 30 days prior to enrollment.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\\< 6 months prior to enrollment), myocardial infarction (\\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n* Mental or psychological illness preventing cooperation with treatment, efficacy evaluations.\n* Participants who have undergone prior organ transplantation, including allogeneic stem-cell transplantation.'}, 'identificationModule': {'nctId': 'NCT05990920', 'briefTitle': 'Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NKGen Biotech, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Dose Escalation Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Participants with Pathologically Confirmed Cancer Refractory to Conventional Therapy', 'orgStudyIdInfo': {'id': 'SNK02-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'SNK02 will be administered as an IV infusion weekly for 8 weeks.', 'interventionNames': ['Biological: SNK02']}], 'interventions': [{'name': 'SNK02', 'type': 'BIOLOGICAL', 'description': "SNK02 is ex vivo expanded allogeneic NK cells for IV injection, is a light-yellow cryopreserved cell suspension consisting of NK cells isolated from healthy donor's peripheral blood mononuclear cells.", 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Angeles Clinic and Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Sarcoma Oncology Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NKGen Biotech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}