[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555960":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":54,"collaborators":32,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":32,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":32,"enrollmentInfo":65,"targetDuration":32,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":32,"overallStatus":74,"whyStopped":32,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Novatim Immune Therapeutics (Zhejiang) Co., Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a: Low dose group","EXPERIMENTAL","Infusion of KQ-2003 CAR T-cells by single dose of 0.5×10\\^6 CAR-T cells\u002Fkg",[13],"Biological: KQ-2003 CAR T-cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1a: Medium dose group","Infusion of KQ-2003 CAR T-cells by single dose of 1.0×10\\^6 CAR-T cells\u002Fkg",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase 1a: High dose group","Infusion of KQ-2003 CAR T-cells by single dose of 2.0×10\\^6 CAR-T cells\u002Fkg",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Phase 1b: RP2D","After all subjects in the Phase 1a dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 1b expansion study.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BIOLOGICAL","KQ-2003 CAR T-cells","KQ-2003 CAR T-cell therapy involves autologous chimeric antigen receptor T-cells, capable of targeting both human B cell maturation antigen (anti-BCMA CAR) and CD19 antigen molecules (anti-CD19 CAR) simultaneously as a cellular therapy.",[19,9,15,23],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Jian Li, M.D.","CONTACT","010-65296114","lijian@pumch.cn",[40],{"facility":41,"status":32,"city":42,"state":32,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Chinese Academy of Medical Sciences & Peking Union Medical College Hospital","Beijing","100730","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"type":55,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100555960","phase-1-a-study-of-kq-2003-car-t-cell-therapy-for-patients-with-relapsed-or-refractory-poems-syndrome-100555960",false,"NCT06518876","A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome","A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Characterization of KQ-2003 for Patients With Relapsed\u002FRefractory POEMS Syndrome","Inclusion Criteria:\n\n* Age ≥18 years old, male or female;\n* Diagnosis of POEMS syndrome with relapsed or refractory disease;\n* Eastern Cooperative Oncology Group (ECOG) Performance ≤2 ;\n* Adequate venous access for the apheresis of peripheral blood mononuclear cell;\n* Vascular Endothelial Growth Factor (VEGF) ≥1200ng\u002FL；\n* Overall Neuropathy Limitations Scale (ONLS) ≥ 1;\n* Adequate organ function;\n* Able and willing to comply with the study protocol and follow-up plan, and sign the informed consent form in writing.\n\nExclusion Criteria:\n\n* Subjects who had previously received BCMA-CD19 dual-target CAR-T cell products or autologous stem cell transplantation within 12 weeks before the collection of peripheral blood mononuclear cells;\n* Known allergy or hypersensitivity reactions to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), CD19, or BCMA-targeted drugs;\n* Received any treatment that might influence the activity of CAR-T cells prior to the collection of peripheral blood mononuclear cells;\n* Have history of vaccination within the 4 weeks preceding the collection of peripheral blood mononuclear cells;\n* Have tested positive for cytomegalovirus and\u002For mycobacterium tuberculosis, or had any uncontrolled active infection within 14 days prior to the collection of peripheral blood mononuclear cells;\n* Subjects infected with active HBV or HCV, HIV, syphilis;\n* Subjects with known central nervous system disease, for example, seizure disorders, clinically significant cerebral ischemia\u002Fhemorrhage, dementia);\n* Subjects currently experiencing active autoimmune diseases; Diagnosed with immunodeficiency or receiving any other form of immunosuppressive therapy within 7 days prior to enrollment in this study;\n* Subjects with active bleeding or VTE events (such as pulmonary embolism or deep vein thrombosis) require anticoagulation;\n* Have following severe diseases: unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction , New York Heart Association (NYHA) Class ≥ III, congestive heart failure, poorly controlled severe arrhythmias or other cardiac diseases requiring mechanical support; subjects with known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal; subjects with known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or currently having any category of uncontrolled asthma; subjects requiring oxygen to maintain adequate oxygen saturation; subjects with hypertension whose blood pressure cannot be lowered to the following range despite treatment with two or more antihypertensive medications;\n* Have active malignancies;\n* Have any non-hematologic toxicity resulting from prior treatments that cannot be restored to ≤ grade 1 or baseline, excluding alopecia and grade 2 neuropathy;\n* Subjects had participated in other clinical trials and used its investigational drugs within the 3 months prior to the collection of peripheral blood mononuclear cells;\n* History of alcohol abuse, drug addiction, substance abuse, or mental illness within the past year;\n* Pregnant or lactating women;\n* Any situation that the investigator believes may increase the risk of subjects or interfere with the results of clinical trials","ALL","18 Years",{"count":66,"type":67},21,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This is a multicenter, open-label, dose-escalation\u002Fexpansion phase 1 study to evaluate the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic characteristics and determine the recommended dose of KQ-2003 CAR T-cells for patients with Relapsed\u002FRefractory POEMS Syndrome",[73],"POEMS Syndrome","NOT_YET_RECRUITING","2024-07-18",{"date":77,"type":78},"2024-07-24","ACTUAL",{"date":80,"type":67},"2024-08-31",{"date":82,"type":67},"2027-12-31",{"name":5,"class":6},1]