Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT06917105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Kinetics of CAR-T cells', 'timeFrame': 'At 3, 6, 9, 12, 18, and 24 months post-treatment follow up', 'description': 'Use flow cytometry or Q-PCR to monitor the kinetics of CAR-T cells.'}], 'primaryOutcomes': [{'measure': 'The incidence of adverse events', 'timeFrame': 'Day 28'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'At 3, 6, 9, 12, 18, and 24 months post-treatment follow up'}, {'measure': 'Complete response rate (CRR)', 'timeFrame': 'At 3, 6, 9, 12, 18, and 24 months post-treatment follow up'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'At 3, 6, 9, 12, 18, and 24 months post-treatment follow up'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'At 3, 6, 9, 12, 18, and 24 months post-treatment follow up'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'At 3, 6, 9, 12, 18, and 24 months post-treatment follow up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloid Malignancies', 'CAR-T']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm, exploratory clinical trial utilizing a "3+3" dose escalation followed by dose expansion to evaluate the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), and preliminary efficacy of CD33/CD123/CLL-1 CAR-T cell therapy in patients with relapsed/refractory myeloid malignancies.\n\nPart A: Dose Escalation Phase. Follows a "3+3" dose escalation design with four predefined dose cohorts: 0.2×10⁶, 0.5×10⁶, 1×10⁶, and 2×10⁶ CAR-positive cells/kg.Anticipated enrollment: 12-24 subjects.Primary objectives: Assess safety, tolerability, and determine MTD.Dose-limiting toxicity (DLT) observation period: 28 days post-infusion.\n\nPart B: Dose Expansion Phase.Enrolls 21 additional subjects to receive CAR-T cell infusion at the recommended Phase 2 dose (RP2D) established in Part A.Primary objective: Further evaluate therapeutic efficacy.\n\nOverall Study Objectives:Safety profile of CD33/CD123/CLL-1 CAR-T therapy.Efficacy endpoints (e.g., response rates, survival outcomes).Pharmacokinetic characterization of CAR-T cells (expansion/persistence).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent: Willing and able to provide written informed consent, with commitment to comply with scheduled visits, study treatment, laboratory tests, and other trial procedures.\n\nAge: ≥18 years, regardless of gender.\n\nDiagnosis: Pathologically confirmed myeloid malignancy (including but not limited to AML or MDS) meeting relapsed/refractory criteria:\n\nRelapsed Disease: Reappearance of leukemic cells in peripheral blood, bone marrow blasts \\>5%, or extramedullary relapse after achieving CR/CRi with ≥2 lines of salvage therapy.\n\nRefractory Disease: Failure to achieve CR/CRi after ≥2 cycles of standard intensive chemotherapy.\n\nAntigen Expression: Tumor cell positivity for CD33, CD123, and/or CLL-1 confirmed by immunohistochemistry (IHC) or flow cytometry.\n\nLife Expectancy: ≥3 months from the date of informed consent signing. Hematologic Criteria: Hemoglobin ≥70 g/L (transfusion permitted).\n\nOrgan Function:\n\nRenal: Serum creatinine ≤1.5×ULN. Cardiac: Left ventricular ejection fraction (LVEF) ≥50%. Pulmonary: Oxygen saturation \\>90% on room air. Hepatic: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.\n\nExclusion Criteria:\n\n* Cardiac Dysfunction: Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) \\<50%.\n\nPulmonary Disease: History of severe pulmonary dysfunction (e.g., chronic respiratory failure, interstitial lung disease, or pulmonary hypertension requiring oxygen therapy).\n\nConcurrent Malignancy: Active/progressive malignancy other than myeloid neoplasms (exceptions: adequately treated non-melanoma skin cancer or carcinoma in situ).\n\nUncontrolled Infection: Active severe infection requiring systemic antimicrobial therapy (antibacterial, antiviral, or antifungal) without clinical resolution.\n\nImmune Disorders:\n\nSevere autoimmune disease requiring immunosuppressive therapy within 6 months. Primary immunodeficiency disorders (e.g., common variable immunodeficiency, severe combined immunodeficiency).\n\nViral Infections:\n\nActive hepatitis B (HBV-DNA ≥2000 IU/mL) or hepatitis C (HCV-RNA positive). HIV infection, AIDS, or untreated syphilis (confirmed by serological testing). Hypersensitivity: History of severe allergic reaction (Grade ≥3) to biological products, including antibiotics.\n\nTransplant Complications: Allogeneic hematopoietic stem cell transplant recipients with:\n\nAcute graft-versus-host disease (GvHD) ≥ Grade II within 3 months. Ongoing immunosuppressive therapy for GvHD within 4 weeks.\n\nGeneral Exclusion:\n\nAny physical, psychiatric, or laboratory abnormality that may:\n\nSignificantly increase study risk (e.g., uncontrolled diabetes, NYHA Class III/IV heart failure).\n\nCompromise protocol compliance or data interpretation. Investigator-determined unsuitability for trial participation.'}, 'identificationModule': {'nctId': 'NCT06917105', 'briefTitle': 'Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies', 'orgStudyIdInfo': {'id': 'TJ-IRB202503062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T Cells infusion（ CD33/CD123/CLL-1 CAR-T）', 'interventionNames': ['Drug: CD33/CD123/CLL-1 CAR-T Cells']}], 'interventions': [{'name': 'CD33/CD123/CLL-1 CAR-T Cells', 'type': 'DRUG', 'description': 'Part A: Dose Escalation Phase. Follows a "3+3" dose escalation design with four predefined dose cohorts: 0.2×10⁶, 0.5×10⁶, 1×10⁶, and 2×10⁶ CAR-positive cells/kg.Anticipated enrollment: 12-24 subjects.Primary objectives: Assess safety, tolerability, and determine MTD.Dose-limiting toxicity (DLT) observation period: 28 days post-infusion.\n\nPart B: Dose Expansion Phase.Enrolls 21 additional subjects to receive CAR-T cell infusion at the recommended Phase 2 dose (RP2D) established in Part A.Primary objective: Further evaluate therapeutic efficacy.', 'armGroupLabels': ['CAR-T Cells infusion（ CD33/CD123/CLL-1 CAR-T）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Jia Wei', 'role': 'CONTACT', 'email': 'jiawei@tjh.tjmu.edu.cn', 'phone': '+8613986102084'}], 'facility': 'Tongji Hospital affiliated to Tongji Medical College of Huazhong University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Jia Wei', 'role': 'CONTACT', 'email': 'jiawei@tjh.tjmu.edu.cn', 'phone': '+86 13986102084'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebei Taihe Chunyu Biotechnology Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Jia Wei', 'investigatorAffiliation': 'Tongji Hospital'}}}}