[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100620821","early-phase-1-exploratory-study-on-in-vivo-car-t-therapy-targeting-cd20-for-the-treatment-of-hematological-malignancies-100620821",false,"NCT07362602","Exploratory Study on in Vivo CAR-T Therapy Targeting CD20 for the Treatment of Hematological Malignancies","Inclusion Criteria:\n\n* 1\\. Age range of 18-70 years old, gender not limited;\n* 2\\. Expected survival time exceeds 12 weeks;\n* 3\\. Diagnosed with blood system tumors such as CD20+B-cell lymphoma or lymphocytic leukemia and meeting the corresponding previous treatment requirements;\n* 4\\. There are assessable lesions (applicable only to lymphoma patients);\n* 5\\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point; Before screening (at baseline), corresponding requirements should be met;\n* 7\\. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;\n* 8\\. Those who can understand this experiment and have signed the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Accompanied by other uncontrolled malignant tumors;\n* 2\\. Received chimeric antigen receptor therapy or other transgenic T cell therapy within 6 months;\n* 3\\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;\n* 4\\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;\n* 5\\. Participants with atrial or ventricular involvement;\n* 6\\. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;\n* 7\\. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;\n* 8\\. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial\u002Fvenous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;\n* 9\\. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;\n* 10\\. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;\n* 11\\. Within 14 days prior to enrollment, there is an active or uncontrollable infection that requires systemic treatment (excluding simple urinary tract infections or upper respiratory tract infections).\n* 12\\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.","ALL","18 Years","70 Years",{"count":19,"type":20},47,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed\u002Frefractory patients still faces significant challenges. CD20 is a transmembrane protein highly expressed on the surface of B cells, almost penetrating the precursor, mature, and activated stages of B cells, but lacking in plasma cells, making it an ideal target for B cell malignancies.\n\nIn recent years, the breakthrough development of in vivo CAR-T therapy has overturned the traditional paradigm of in vitro CAR-T technology. The core principle is to directly deliver the gene encoding chimeric antigen receptor (CAR) to T cells in the patient's body through gene delivery vectors, without the need for in vitro isolation, modification, and amplification processes, and to complete the gene reprogramming of T cells in vivo. At present, the mainstream carrier technologies for CAR-T therapy in vivo are divided into two categories: lentiviral carriers and lipid nanoparticle (LNP) carriers. LNP carriers have significantly broken through the clinical bottlenecks of traditional CAR-T in terms of cost and accessibility, safety, and timeliness.\n\nThis experimental drug is a CD20 based messenger ribonucleic acid (mRNA) therapeutic drug, which is an injection formed by loading mRNA onto lipid nanoparticles (LNP). It has shown efficient B-cell clearance activity and good safety in non clinical settings, supporting further clinical exploration in B-cell hematological malignancies. It is expected to provide an innovative, safe, and accessible immunotherapy for B-cell hematological malignancies and bring better clinical benefits to more patients with B-cell hematological malignancies.",[26],"Hematological Malignancies","NOT_YET_RECRUITING","2026-01-15",{"date":30,"type":31},"2026-01-23","ACTUAL",{"date":33,"type":20},"2026-01-26",{"date":35,"type":20},"2028-12-31",{"name":37,"class":38},"The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100524336","early-phase-1-safety-and-efficacy-of-rm-004-cells-for-hemoglobin-h-constant-spring-disease-100524336","NCT06107400","Safety and Efficacy of RM-004 Cells for Hemoglobin H-Constant Spring Disease","Study to Evaluate the Safety and Efficacy of RM-004 Cells for the Treatment of Hemoglobin H-Constant Spring Disease","Inclusion Criteria:\n\n1. Subjects voluntarily sign informed consent by themselves or their legal guardians and complete the study procedures, follow-up examination and treatment.\n2. At the time of screening, subjects should be aged from 12 to 35 years old, regardless of gender.\n3. History of at least 100 mL\u002Fkilograms (kg)\u002Fyear of packed red blood cells (pRBC) transfusions in the prior 2 years before screening.\n4. Subjects diagnosed with Hemoglobin H-Constant Spring disease (--\u002FααCS) with HBA2 c.427T\\>C mutation.\n\nExclusion Criteria:\n\n1. Subject who has an available HLA-matched\u002Fwell-matched HSCT donor for allogeneic hematopoietic stem cell transplantation (HSCT).\n2. Prior HSCT or gene therapy.\n3. History of severe hemorrhagic disease.\n4. Clinically significant active bacterial, viral, fungal or parasitic infections per investigator's judgement at the time of screening.","12 Years","35 Years",{"count":49,"type":20},5,[23],"The purpose of this study is to evaluate the safety and efficacy of RM-004 for Hemoglobin H-Constant Spring disease.",[53,54,55],"Alpha Thalassemia Hemoglobin H Constant Spring","Hemoglobinopathies","Hereditary Diseases",[57,58,59,60,61],"RM-004","Hemoglobin H-Constant Spring disease","Alpha-Thalassemia","Gene therapy","CBE","RECRUITING","2024-05-30",{"date":65,"type":31},"2024-06-03",{"date":67,"type":31},"2023-10-08",{"date":69,"type":20},"2026-10-31",{"name":37,"class":38},1,""]