Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT07144020
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Donor Derived CD117 CAR-T Cells in the Treatment of R/R 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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Up to 28 days after Treatment', 'description': 'Adverse events assessed according to NCI-CTCAE v5.0 criteria'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years after Treatment', 'description': 'Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Complete response (CR), and complete response with incomplete hematologic recovery (CRi)', 'timeFrame': 'Up to 12 weeks after CAR-T infusion', 'description': 'The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).'}, {'measure': 'Duration of remission ,DOR', 'timeFrame': 'Up to 1 years after CAR-T infusion', 'description': 'The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion'}, {'measure': 'Overall survival, OS', 'timeFrame': 'Up to 1 years after CAR-T infusion', 'description': 'The time from CAR-T infusion to death due to any cause'}, {'measure': 'Leukemia-Free Survival, LFS', 'timeFrame': 'Up to 2 years after Treatment', 'description': 'The time from CAR-T infusion torecurrence or metastasis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD117 CAR-T'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia', 'detailedDescription': 'This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD117 CAR-T Cell in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 15-50 participants in this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients with a histologically or immunophenotypically confirmed diagnosis of CD117-positive Acute Myeloid Leukemia (AML).\n* 2\\. Diagnosis must meet the 2016 WHO classification criteria for AML and fulfill the definitions for relapsed or refractory disease per the \\*Chinese Guidelines for the Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition)\\*, with no available suitable standard therapeutic options or registered clinical trials.\n* a). Relapsed AML: Defined as the reappearance of leukemic blasts in the peripheral blood, bone marrow blast count \\>5% (when assessed morphologically, after excluding regenerative changes post-consolidation chemotherapy), or development of extramedullary disease after achieving a Complete Remission (CR).\n* b). Refractory AML (meeting at least one criterion): Failure to achieve CR following two cycles of standard induction therapy in newly diagnosed patients; relapse within 12 months after CR following consolidation therapy; relapse beyond 12 months that fails to respond to conventional salvage chemotherapy; ≥2 relapses; or persistent extramedullary leukemia.\n* 3\\. Presence of \\>5% bone marrow blasts (by morphology) and/or \\>1% (by flow cytometric analysis).\n* 4\\. Total bilirubin ≤1.5 × ULN (≤51 μmol/L) ALT and AST ≤3 × ULN Serum creatinine ≤1.5 × ULN (≤176.8 μmol/L)\n* 5\\. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.\n* 6\\. Oxygen saturation ≥92% on room air.\n* 7\\. Life expectancy ≥3 months.\n* 8\\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.\n* 9\\. For patients of childbearing potential: Agreement to use highly effective contraception from screening, throughout the study treatment period, and for at least 6 months after the cell infusion (due to unknown risks to the fetus).\n* 10\\. Voluntary participation, understanding of the study procedures, and provision of written informed consent by the patient or their legally authorized representative.\n\nExclusion Criteria:\n\n* 1\\. Patients with the history of epilepsy or other CNS disease;\n* 2\\. Patients with prolonged QT interval time or severe heart disease;\n* 3\\. Active infection with no cure;\n* 4\\. Active infection of hepatitis B virus or C virus ;\n* 5\\. Before using any gene therapy products;\n* 6\\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;\n* 7\\. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining;\n* 8\\. Infected with AIDS virus;\n* 9\\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.'}, 'identificationModule': {'nctId': 'NCT07144020', 'briefTitle': 'Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Donor Derived CD117 CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'TXB2024010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T cells（ chimeric antigen receptor T cells）', 'description': 'Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.', 'interventionNames': ['Biological: CD117 CAR T-cells']}], 'interventions': [{'name': 'CD117 CAR T-cells', 'type': 'BIOLOGICAL', 'otherNames': ['CD117 CAR T-cells injection'], 'description': 'Each subject receive CD117 CAR T-cells by intravenous infusion', 'armGroupLabels': ['CAR-T cells（ chimeric antigen receptor T cells）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '057187233772'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '057187233772'}], 'facility': 'The first affiliated hospital of medical college of zhejiang university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '057187233772'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '057187233772'}], 'overallOfficials': [{'name': 'He Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yake Biotechnology Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}