[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586571":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":11,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T Cells infusion（ CD33\u002FCD123\u002FCLL-1 CAR-T）","EXPERIMENTAL",null,[13],"Drug: CD33\u002FCD123\u002FCLL-1 CAR-T Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","CD33\u002FCD123\u002FCLL-1 CAR-T Cells","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\u002Fkg.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.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Jia Wei","CONTACT","+86 13986102084","jiawei@tjh.tjmu.edu.cn",[27],{"facility":28,"status":11,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Tongji Hospital affiliated to Tongji Medical College of Huazhong University","Wuhan","Hubei","430030","China","CN",{"type":35,"coordinates":36},"Point",[37,38],114.26667,30.58333,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":42,"phoneExt":11,"email":25},"+8613986102084",{"type":44,"investigatorFullName":22,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","chief physician",[47],{"name":48,"class":49},"Hebei Taihe Chunyu Biotechnology Co., Ltd","INDUSTRY","100586571","phase-1-exploratory-clinical-study-on-the-safety-and-efficacy-of-car-t-cell-therapy-in-the-treatment-of-relapsedrefractory-myeloid-malignancies-100586571",false,"NCT06917105","Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed\u002FRefractory Myeloid Malignancies","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\u002Frefractory criteria:\n\nRelapsed Disease: Reappearance of leukemic cells in peripheral blood, bone marrow blasts \\>5%, or extramedullary relapse after achieving CR\u002FCRi with ≥2 lines of salvage therapy.\n\nRefractory Disease: Failure to achieve CR\u002FCRi after ≥2 cycles of standard intensive chemotherapy.\n\nAntigen Expression: Tumor cell positivity for CD33, CD123, and\u002For 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\u002FL (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\u002FAST ≤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) \\\u003C50%.\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\u002Fprogressive 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\u002FmL) 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\u002FIV heart failure).\n\nCompromise protocol compliance or data interpretation. Investigator-determined unsuitability for trial participation.","ALL","18 Years",{"count":59,"type":60},45,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","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\u002FCD123\u002FCLL-1 CAR-T cell therapy in patients with relapsed\u002Frefractory 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\u002Fkg.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\u002FCD123\u002FCLL-1 CAR-T therapy.Efficacy endpoints (e.g., response rates, survival outcomes).Pharmacokinetic characterization of CAR-T cells (expansion\u002Fpersistence).",[67,68],"Myeloid Malignancies","CAR-T","NOT_YET_RECRUITING","2025-04-01",{"date":72,"type":73},"2025-04-08","ACTUAL",{"date":70,"type":60},{"date":76,"type":60},"2029-04-30",{"name":5,"class":6},1]