[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609266":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":19,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":19,"enrollmentInfo":54,"targetDuration":19,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MSC","EXPERIMENTAL","Mesenchymal stem cells: intravenous infusion, 2×10⁶ cells\u002Fkg body weight\u002Fweek (once weekly), with 1 to 4 administrations based on different dosage groups.",[13],"Biological: Mesenchymal Stem Cell Infusion",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Mesenchymal Stem Cell Infusion",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Zhenzhen Wang","CONTACT","22-23608095","wangzhenzhen@ihcams.ac.cn",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology)","RECRUITING","Tianjin","300020","China","CN",{"type":35,"coordinates":36},"Point",[37,38],117.17667,39.14222,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":43,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100609266","early-phase-1-safety-and-efficacy-of-umbilical-cord-blood-derived-mesenchymal-stem-cells-in-the-treatment-of-long-term-cytopenia-after-car-t-therapy-100609266",false,"NCT07212335","Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy","Single-Arm, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy","MSC-ICAHT","Inclusion Criteria\n\nPatients must meet all the following criteria to be enrolled in this study:\n\n* 1.Voluntarily participate in the study and sign the informed consent form;\n* 2.Aged ≥ 18 years, regardless of gender;\n* 3.Patients with acute lymphoblastic leukemia (ALL), lymphoma, or myeloma who still have severe cytopenia (meeting any of the following conditions: absolute neutrophil count ≤ 1×10⁹\u002FL; platelet count ≤ 30×10⁹\u002FL; hemoglobin ≤ 70 g\u002FdL) 3 weeks after CAR-T cell infusion;\n* 4.ECOG performance status score ≤ 2;\n* 5.Estimated survival time ≥ 6 months;\n* 6.For female patients of childbearing potential, a negative pregnancy test result is required. Female patients of childbearing potential and male patients must use highly effective contraceptive measures during the study period and for 4 months\u002F6 months after the discontinuation of treatment, respectively.\n\nExclusion Criteria\n\nPatients with any of the following conditions are prohibited from enrolling in this study:\n\n* 1.Having received other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hematopoietic stem cell transplantation) that may affect the hematopoietic system or blood cell count within 1 month before the screening period after CAR-T cell infusion;\n* 2.Significant bone marrow infiltration by tumor cells during the screening period (for ALL: bone marrow morphological examination showing leukemia cell proportion \\> 5%; for multiple myeloma (MM) and lymphoma: bone marrow flow cytometry showing positive minimal residual disease (MRD), or bone marrow pathological immunohistochemistry showing lymphoma\u002Fclonal plasma cell infiltration);\n* 3.Presence of any of the following conditions within 1 week before the first dose administration: infection with hemodynamic instability (requiring vasoactive drug support); deep fungal infection confirmed by imaging or microbiology (e.g., invasive aspergillosis, bloodstream infection, etc.); Pneumocystis jirovecii pneumonia, active tuberculosis, viremia (cytomegalovirus, parvovirus B19, etc.), and viral pneumonia (cytomegalovirus, COVID-19 virus, influenza virus, adenovirus, parainfluenza virus, etc.); as well as other severe infections that may affect hematopoiesis as judged by the investigator;\n* 4.Serum creatinine or blood urea nitrogen ≥ 1.5 times the upper limit of normal (ULN);\n* 5.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times ULN; total bilirubin ≥ 1.5 times ULN;\n* 6.Other severe and\u002For uncontrolled diseases, or conditions that may affect study participation as judged by the investigator, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, second-degree to third-degree atrioventricular block, etc.), corrected QT interval using Fridericia's formula (QTcF) \\> 480 ms on electrocardiogram; New York Heart Association (NYHA) heart function classification of Grade Ⅲ-Ⅳ; uncontrolled diabetes mellitus (glycated hemoglobin \\[HbA1c\\] \\> 9%); refractory hypertension; chronic obstructive pulmonary disease (forced expiratory volume in 1 second \\[FEV1\\] \\\u003C 50% of predicted value), etc.;\n* 7.History of arteriovenous thrombosis or atherosclerosis;\n* 8.Positive for anti-human immunodeficiency virus (HIV) antibody or anti-Treponema pallidum specific antibody; positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody with hepatitis B virus deoxyribonucleic acid (HBV-DNA) \\> ULN; or hepatitis C virus ribonucleic acid (HCV-RNA) \\> ULN;\n* 9.A history of or current malignant solid tumor (except cured non-invasive basal cell or squamous cell carcinoma of the skin and\u002For other cured carcinoma in situ; except other malignant tumors that have achieved clinical cure for \\> 5 years with no recurrence within 5 years);\n* 10.Within 6 months after allogeneic hematopoietic stem cell transplantation, or donor cell chimerism rate ≤ 95%, or presence of active acute graft-versus-host disease (aGVHD) of Grade Ⅱ or higher, or moderate to severe chronic graft-versus-host disease (cGVHD);\n* 11.Having received a live vaccine within 4 weeks before the first dose administration, or planning to receive any live vaccine during the study period;\n* 12.Pregnant or lactating female patients;\n* 13.Patients with mental disorders;\n* 14.Participation in any other study drug trial (including vaccine trials) or exposure to other study drugs within 4 weeks or 5 half-lives (whichever is longer) before the first dose administration;\n* 15.Patients who refuse to sign the informed consent form;\n* 16.Other conditions deemed unsuitable for study inclusion by the investigator.","ALL","18 Years",{"count":55,"type":56},15,"ESTIMATED","INTERVENTIONAL",[59],"EARLY_PHASE1","This study is a single arm, open label, exploratory clinical study aimed at evaluating the efficacy, and safety of allogeneic umbilical cord blood-derived mesenchymal stem cells in the treatment of long-term cytopenia after CAR-T therapy.",[62],"Immune Effector Cell Associated Hematotoxicity",[64,65,66,67],"ICAHT","hematotoxicity","CAR-T","cytopenia","2026-02-09",{"date":70,"type":71},"2026-02-11","ACTUAL",{"date":73,"type":71},"2025-10-01",{"date":75,"type":56},"2028-09-30",{"name":5,"class":6},1]