Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-25 @ 4:08 PM
Study NCT ID:
NCT05247957
Status:
TERMINATED
Last Update Posted:
2023-01-13
First Post:
2022-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'end', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Limiting Toxicity', 'timeFrame': '28 days', 'description': 'To evaluate the clinical safety and short-term efficacy of NKG2D ligand-specific umbilical cord blood CAR-NK cells in the treatment of patients with relapsed refractory acute myeloid leukemia by intravenous infusion'}, {'measure': 'Maximal Tolerable Dose', 'timeFrame': '28 days', 'description': 'tolerability evaluationtransplantation after intravenous infusion of NKG2D ligand-specific umbilical cord blood CAR-NK cells for patients with relapsed refractory acute myeloid leukemia'}], 'secondaryOutcomes': [{'measure': 'leukemia-free survival#LFS#', 'timeFrame': '52weeks', 'description': 'leukemia-free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NKG2D CAR-NK', 'Relapsed or Refractory Acute Myeloid Leukemia'], 'conditions': ['Safety and Efficacy']}, 'descriptionModule': {'briefSummary': 'This trial will explore the maximum tolerated dose of cord blood NKG2D CAR-NK in the treatment of recurrent refractory acute myeloid leukemia in a dose-escalation manner, and observe its clinical safety and efficacy.', 'detailedDescription': 'This is a single arm, open-label, Phase 1 study initiated with 3 cohorts:\n\nCohort 1: 2×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 2: 6×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 3: 18×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: ≥ 10 years old and ≤ 75 years old, male or female;\n2. Meet the diagnostic criteria for recurrent AML: detection of leukemia cells after complete remission (CR) or \\>0.1% of leukemia cells in bone marrow, including recurrence after allogeneic hematopoietic stem cell transplantation, or extramedullary infiltration of leukemia cells;\n3. Initial cases with failure of 2 lines of standard treatment; patients who relapsed within 12 months after consolidation intensification after CR; recurrence in 12 months and no respond to conventional chemotherapy; 2 or more recurrences; persistent extramedullarial leukemia;\n4. Patients currently have no effective treatment options, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or patients voluntarily choose to infuse NKG2D CAR-NK cells as the first treatment option;\n5. Physical status assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;\n6. Estimated survival \\> 3 months\n7. Flow cytometry check for NKG2D ligand expression on the surface of cancer cells for a reference of selecting patients\n8. The main organs of the patient are well functioned: (1) cardiac function: no heart disease or coronary heart disease, the patient's cardiac function grade 1-2; (2) liver function: TBIL≦3ULN, AST≦2.5ULN, ALT≦2.5ULN; (3) Renal function: Cr≦1.25ULN;\n9. The patient's peripheral superficial vein can meet the needs of intravenous injection;\n10. No other serious diseases that conflict with this protocol (e.g., autoimmune diseases, immunodeficiency, organ transplantation);\n11. No history of other malignant tumors;\n12. Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;\n13. Subjects have negative HIV, HBV, HCV, syphilis serology test results\n14. Written informed consent form must be signed before enrollment.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (type M3);\n2. Patients with cardiac insufficiency, patients with hepatic and renal insufficiency;\n3. Those who need treatment with other malignant tumors;\n4. Poorly controlled hypertension (systolic blood pressure \\>160 mmHg and/or diastolic blood pressure \\>90 mmHg) or clinically significant cardiovascular and cerebrovascular diseases such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent), unstable angina, congestive heart failure, or severe arrhythmias that cannot be controlled with drugs or have a potential impact on research treatment;\n5. Also suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for inductees);\n6. Diffuse vascular internal coagulation;\n7. Concomitant serious infection or other serious underlying medical condition;\n8. Have immunodeficiency and autoimmune diseases;\n9. Have severe allergic diseases;\n10. Clinical symptoms of brain dysfunction or severe mental illness that can not understand or follow the research protocol;\n11. Have participated in clinical trials of other drugs within 4 weeks or within 21 days of surgery;\n12. Have received cell therapy in the previous 1 month;\n13. Have received hormonal drug therapy in the previous 14 days;\n14. Known HIV-positive patients or hepatitis B and C patients and syphilis patients;\n15. Have received organ transplants (excluding stem cell transplant patients);\n16. Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study;\n17. Pregnant or lactating women;\n18. Those who cannot be followed up as scheduled;\n19. Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study."}, 'identificationModule': {'nctId': 'NCT05247957', 'briefTitle': 'NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Cheetah Cell Therapeutics Co., Ltd'}, 'officialTitle': 'NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'CARNK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NKG2DL-specific CAR-NK cells', 'description': 'Experimental: NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7 After preconditioning with chemotherapy, NKG2DL-specific CAR-NK cells will be evaluated', 'interventionNames': ['Biological: CAR-NK cells']}], 'interventions': [{'name': 'CAR-NK cells', 'type': 'BIOLOGICAL', 'otherNames': ['NKG2DL-specific CAR-NK cells'], 'description': 'NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7', 'armGroupLabels': ['NKG2DL-specific CAR-NK cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanhe', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei Yanda Lu Daopei Hospital', 'geoPoint': {'lat': 39.98049, 'lon': 117.06887}}], 'overallOfficials': [{'name': 'Peihua Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Yanda Lu Daopei Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Cheetah Cell Therapeutics Co., Ltd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}