[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"poems-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:poems-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,67,93,132,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100641381","phase-2-kcd-carfilzomibcyclophosphamidedexamethasone-regimen-for-the-treatment-of-newly-diagnosed-poems-syndrome-100641381",false,"NCT07652879","KCD (Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome","A Single-center, Prospective, Open-label Investigation of the KCD (Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome","Inclusion Criteria:\n\n1. Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version);\n2. Age 18-75 years;\n3. ECOG performance status 0-3, with an estimated life expectancy \\>3 months;\n4. No active infective diseases;\n5. No prior anti-POEMS therapy except for corticosteroids;\n6. No severe organic impairment of major organs, meeting the following laboratory requirements: creatinine clearance ≥40 mL\u002Fmin, total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN; cardiac enzymes \\\u003C2 × ULN; left ventricular ejection fraction within normal range on echocardiography, and no clinically significant electrocardiogram abnormalities;\n7. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL without prior growth factor support; platelet count ≥50 × 10\\^9\u002FL without platelet transfusion within 7 days prior to screening; hemoglobin ≥60 g\u002FL;\n8. Ability to swallow and take medication orally;\n9. Completion of all screening and assessments as outlined in the study protocol;\n10. Signed informed consent for chemotherapy.\n\nExclusion Criteria:\n\n1. POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia;\n2. HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA \\>10\\^2 copies\u002FmL;\n3. Concurrent severe unstable medical conditions, including heart failure, renal failure, liver failure, bleeding disorders, arterial\u002Fvenous thrombotic events within 6 months, uncontrolled diabetes mellitus, or a history of active hemorrhagic cystitis;\n4. History of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that caused end-organ damage or required systemic immunosuppressive or disease-modifying therapy;\n5. Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis);\n6. Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival \\>5 years);\n7. Epilepsy requiring medication, dementia, or other mental status abnormalities that interfere with understanding or complying with the study protocol;\n8. Drug use, medical, psychological, or social conditions that may interfere with study participation or outcome assessment;\n9. Pregnancy or breastfeeding;\n10. Any condition deemed by the investigator to make the patient unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a single-center, prospective, open-label clinical study to evaluate the efficacy and safety of KCD(Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) regimen in subjects with newly diagnosed POEMS Syndrome.",[27],"POEMS Syndrome",[29],"POEMS syndrome, Carfilzomib","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":21},"2026-06-15",{"date":38,"type":21},"2028-01",{"name":40,"class":41},"Shanghai Changzheng Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100627461","one-gene-two-diseases-the-pathologic-role-of-iglv1-44-in-al-amyloidosis-and-poems-100627461","NCT07448935","One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS","ALPS","Inclusion Criteria:\n\n* Biopsy-proven diagnosis of systemic AL amyloidosis, POEMS syndrome or multiple myeloma\n* Planned peripheral blood sampling +\u002F- bone marrow aspiration\n* Age \\> 18 years\n* Willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes through signing a written informed consent.\n\nExclusion Criteria:\n\n* Undefined monoclonal gammopathy or non-AL amyloidosis\n* Patients fulfilling the criteria for complete hematologic response after anti-clonal therapy\n* Age \\\u003C18 years\n* Failure to show willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes.","99 Years",{"count":52,"type":21},100,"OBSERVATIONAL","By detailed sequence analysis and subsequent biophysical characterization of prototypic light chains, this project aims to identify sequence fingerprints in IGLV1-44 light chains leading to AL amyloidosis and POEMS syndrome. This understanding might help improve the risk stratification and early diagnosis of patients overexpressing pathologic IGLV1-44 LCs. Moreover, the development of nanobodies efficient in recognizing and stabilizing IGLV1-44 light chains which exert direct toxicity in cardiac AL amyloidosis and POEMS syndrome might form the basis for future development of therapeutic agents capable of counteracting IGLV1-44 light chain proteotoxicity.",[56,27,57],"AL Amyloidosis","Multiple Myeloma","2026-04-30",{"date":60,"type":34},"2026-05-06",{"date":62,"type":34},"2025-11-28",{"date":64,"type":21},"2026-06-30",{"name":66,"class":41},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100601834","phase-2-bcmacd3-bsab-therapy-for-poems-syndrome-100601834","NCT07115654","BCMA\u002FCD3 BsAb Therapy for POEMS Syndrome","A Prospective Single-Arm Clinical Trial of BCMA\u002FCD3 BsAb Therapy for POEMS Syndrome","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Diagnosed with POEMS syndrome according to the 2025 Chinese Expert Consensus.\n3. Deemed suitable for BCMA\u002FCD3 bispecific antibody therapy by the investigator.\n4. ECOG performance status 0-2.\n5. Adequate organ function.\n6. Provided written informed consent.\n\nExclusion Criteria:\n\n1. Not meeting the diagnostic criteria for POEMS syndrome, including:\n\n   * Chronic inflammatory demyelinating polyneuropathy (CIDP),\n   * MGUS, multiple myeloma, amyloidosis, or other plasma cell disorders not meeting POEMS diagnostic criteria.\n2. History of prior anti-plasma cell therapy, such as melphalan, cyclophosphamide, proteasome inhibitors, IMiDs, monoclonal antibodies, CAR-T, or bispecific antibodies (except:\n\n   1. Immunosuppressants used for autoimmune neuropathy;\n   2. Bisphosphonates used for bone disease;\n   3. Topical or low-dose steroids ≤20 mg\u002Fday for rheumatic disease).\n3. Investigator judges the patient unsuitable for BCMA\u002FCD3 bispecific therapy (e.g., severe cardiopulmonary dysfunction).\n4. Known allergy or intolerance to BCMA\u002FCD3 bispecific antibody or any component.","78 Years",{"count":76,"type":21},10,[24],"This is a prospective, single-arm, investigator-initiated clinical trial evaluating the safety and efficacy of a BCMA\u002FCD3 bispecific antibody (CM336) in patients with POEMS syndrome.",[27],[81,82],"POEMS syndrome","Bispecific antibody","NOT_YET_RECRUITING","2025-08-04",{"date":86,"type":34},"2025-08-11",{"date":88,"type":21},"2025-08-10",{"date":90,"type":21},"2027-12-01",{"name":92,"class":41},"Institute of Hematology & Blood Diseases Hospital, China",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":104,"conditions":105,"keywords":114,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":42},"100519209","polyneuropathy-impairments-and-physical-activity---the-polyimpact-study-100519209","NCT06040567","Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study","PolyImPAct","Inclusion Criteria:\n\nInclusion Criteria patients:\n\n\\> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)\n\nInclusion Criteria healthy controls:\n\n\\> 18 years Healthy\n\nExclusion Criteria:\n\nExclusion Criteria patients:\n\nNot verified polyneuropathy\n\nExclusion Criteria healthy controls:\n\nDiabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy",true,"100 Years",{"count":103,"type":21},520,"The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.",[106,107,27,108,109,110,111,112,113],"Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Vasculitic Neuropathy","Multifocal Motor Neuropathy","Charcot-Marie-Tooth","hATTR Amyloidosis","Diabetic Polyneuropathy","Idiopathic Neuropathy","Polyneuropathies",[115,116,117,118,119,120,121,122],"Polyneuropathy","Clinical outcome measures","Patient reported outcome measures (PROMs)","Physical activity","Accelerometer","Validity","Reliability","Responsiveness","2025-04-03",{"date":125,"type":34},"2025-04-06",{"date":127,"type":34},"2023-09-23",{"date":129,"type":21},"2026-12-31",{"name":131,"class":41},"Rigshospitalet, Denmark",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":155,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":42},"100405605","early-phase-1-safety-and-efficacy-of-ct103a-cells-for-relapsedrefractory-antibody-associated-inflammatory-diseases-of-the-nervous-system-100405605","NCT04561557","Safety and Efficacy of CT103A Cells for Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","CARTinNS","Inclusion Criteria:\n\n1. Male or female subjects aged 18-75 years (including 18 and 75 years);\n2. Subjects with Relapsing\u002Frefractory Antibody-mediated inflammatory diseases of the nervous system without effective treatment, including:\n\n   1. Subjects must be diagnosed as AQP4-IgG-positive NMOSD defined by 2015 criteria of IPND NMOSD and meet the following requirements: i. At least one kind of immunosuppressant has been used for more than one year with poorly-controlled symptoms; ii. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.\n   2. Subjects with MG with positive abnormal antibody, MG-ADL total score ≥ 6 points, MGFA classification II-IV defined by 2020 MGFA diagnostic criteria and meet the following requirement: i. At least one kind of immunosuppressant for standardized treatment for more than 1 year, and have one of the following poor control conditions: 1) continuous inability to affect daily life; 2) Exacerbation of MG symptoms and\u002For crisis attacks still occur despite standard treatment; 3) Inability to tolerate immunosuppressive therapy ii. Requires plasma exchange or maintenance therapy with IV gamma globulin\n   3. Subjects with CIDP with positive abnormal antibodies, INCAT disability scale with total score of 2-9 defined by 2021 EAN\u002FPNS diagnostic criteria and meet the following requirement: i. Standardized use of at least one first-line therapy for more than 3 months (cortisol hormone therapy, gamma globulin or plasma exchange therapy) with poorly-controlled symptoms. ii. Inability to tolerate cortisol hormones, gamma globulin, and plasmapheresis because of side effects or other conditions\n   4. Subjects were diagnosed with IIM defined by 2017 European League against Rheumatism\u002FAmerican Rheumatology (EULAR\u002FACR) conference Class criteria; At least one kind of cardiac enzymes (CK, AST, ALT, ALD, LDH) ≥1.5×ULN during the screening period, or Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) ≥6, or at least one other sign of active disease within the last 6 months: MRI, EMG, or muscle biopsy; positive serological tests for myositis-specific antibodies (MSA) or myositis-associated autoantibodies (MAA), or antinuclear antibody (ANA). and meet one of the following requirements:\n\n   i. After at least 1 month of corticosteroid therapy and standardized use of at least one immunosuppressant\u002Fmodulator (eg, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, Cyclophosphamide, leflunomide, intravenous gamma globulin, etc.) for more than 3 months with poorly-controlled symptoms.\n\n   ii. ii. Inability to tolerate the above traditional regimens due to side effects or other conditions;\n\n   e. Subjects were diagnosed with PMS (including PPMS and SPMS) or RMS according to the 2017 revision of the McDonald diagnostic criteria；EDSS score between 2 to 7 points inclusive, at screening. Subjects with RMS should meet one of the following requirements after standard therapy: i. at least two relapses in the last two years before screening. ii. at least one relapse in the last one year before screening. iii. positive Gd-enhancing MRI in the last one year before screening.\n\n   f. Subjects were diagnosed with POEMS syndrome according to the 2021 revised IMWG diagnostic criteria and meet all of the following requirements: i. bone marrow involvement; ii. no response to traditional regimens treatment including corticosteroid, chemotherapy, protease inhibitor or inability to tolerate the above traditional regimens; iii. Have measurable lesions (refer to the 2021 revised IMWG standard) iv. VEGF \\> 2 ULN; v. ECOG score ≥1; vi. ONLS score ≥1.\n\n   g. Subjects were diagnosed with autoimmune encephalitis according to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis and meet all of the following requirements: i. at least one pathogenic antibody positive; ii. previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance; iii. onset of autoimmune encephalitis within 3 months prior to screening; iv. mRS Score ≥2 or CASE score ≥4.\n\n   h. Subjects were diagnosed with MOGAD according to the 2023 International MOGAD Diagnostic criteria and meet all of the following requirements: i. a documented positive serum MOG Ab test using a cell-based assay (CBA); ii mRS Score ≥2; iii previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance.\n3. All acute toxic reactions resolved to baseline or ≤ grade 1 assessed using NCI-CTCAE v5.0 except the ones adjudicated by the investigator to pose no risks on subjects.\n4. Enrolled subjects must have satisfactory organ function and laboratory findings as defined by the following:i. Blood tests: absolute neutrophil count ≥ 2×109\u002FL (or normal lower limit set by the central lab of the institution), platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 100 g\u002FL; ii. Liver function: total serum bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤ 1.5x the institutional normal upper limit (ULN); iii. Kidney function: CrCl ≥ 60 ml\u002Fmin\u002F1.73m2 (according to the following Cockcroft-Gault formula); iv. Electrolytes: blood potassium ≥ 3.0 mmol\u002FL; blood calcium ≥ 2.0 mmol\u002FL, blood magnesium ≥ 0.5 mmol\u002FL; v. Coagulation function: fibrinogen ≥ 1.0 g\u002FL; APTT ≤ ULN + 10s; PT ≤ ULN + 3s.\n5. Blood oxygen saturation \\> 91% in resting state.\n6. Echocardiography suggests LVEF≥ 50%.\n7. Expected life expectancy ≥ 12 weeks as assessed by the investigator.\n8. After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CT103A cells infusion (excluding contraception safety periods).\n9. Subjects must provide written informed consent before the study begin.\n\nExclusion Criteria:\n\n1. Patients do not have adequate mononuclear cells without mobilization for CAR-T cell manufacturing.\n2. History of autoimmune hemolytic disease.\n3. History of solid organ transplantation.\n4. Patients were treated with alemtuzumab within 6 months prior to apheresis. Patients were treated with fludarabine or cladribine within 3 months prior to apheresis.\n5. Patients with Papovaviruses infection.\n6. Patients have been diagnosed with malignancies in the last 2 years prior to screening except for non-melanoma skin cancer, stage I cancers with complete resection and low risk of relapse, localized prostate cancer post-treatments, biopsy-confirmed in situ cervical cancer, or squamous epithelial lesion by PAP smear.\n7. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.\n8. MG crisis was not effectively controlled within 2 weeks before enrollment.\n9. Known history of primary immunodeficiency (innate or acquired).\n10. Patients with severe impaired cardiac function, including but not limited to the following: unstable angina, myocardial infarction (within 6 months before enrollment), congestive heart failure (≥Grade III by NYHA), severe ventricular arrhythmia.\n11. Cerebrovascular accidents, including transient ischemic attack or stroke history, occurred within 6 months before enrollment.\n12. Major operation or surgical treatment caused by any reason within 4 weeks before enrollment.\n13. Any serious and\u002For uncontrolled comorbidities which may interfere with the evaluation during the study in the opinion of the investigator\n14. Previous treatments: History of thymectomy within 12 months prior to CT103A infusion;\n15. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n16. Prone to allergies or history of serious allergy.\n17. Pregnant or lactating women.\n18. Patients with other conditions adjudicated by the investigator as unsuitable for enrollment.\n\nCriteria for lymphodepletion and CAR-T cells infusion:\n\nBefore lymphocyte depletion and CAR-T cells infusion, patients are evaluated and those meeting the following criteria cannot be included:\n\n1. Blood tests: neutrophil count \\\u003C 2 × 109\u002FL, platelet count \\\u003C 50 × 10\\^9\u002FL;\n2. Oxygen inhalation is required to maintain blood oxygen saturation ≥ 91%;\n3. Patients have the following conditions, including but not limited to: new arrhythmia cannot be controlled by drugs; hypotension requiring pressor drugs; bacterial, fungal or viral infection requiring intravenous antibiotic treatment; creatinine clearance rate \\\u003C 50 ml\u002Fmin ;\n4. Patients require maintenance support treatment within one week to meet the criteria for lymphodepletion or CAR T cell infusion.\n5. Cell infusion is delayed \\> 7 days after lymphodepletion for any reason;\n6. Patients with other conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.",{"count":141,"type":21},36,[143],"EARLY_PHASE1","Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed\u002Frefractory antibody-mediated idiopathic inflammatory diseases.",[146,147,148,149,150,151,152,153,154,27],"Autoimmune Diseases","Autoimmune Diseases of the Nervous System","Neuromyelitis Optica Spectrum Disorder","Myasthenia Gravis","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Idiopathic Inflammatory Myopathies","Multiple Sclerosis","Autoimmune Encephalitis","Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)",[156,157,158,147],"Adoptive T Cell Therapy","Chimeric antigen receptor","B-cell maturation antigen (BCMA)","2024-10-27",{"date":161,"type":34},"2024-10-30",{"date":163,"type":34},"2020-09-22",{"date":165,"type":21},"2027-05-31",{"name":167,"class":41},"Tongji Hospital",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":42},"100555960","phase-1-a-study-of-kq-2003-car-t-cell-therapy-for-patients-with-relapsed-or-refractory-poems-syndrome-100555960","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",{"count":176,"type":21},21,[178],"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",[27],"2024-07-18",{"date":183,"type":34},"2024-07-24",{"date":185,"type":21},"2024-08-31",{"date":187,"type":21},"2027-12-31",{"name":189,"class":190},"Novatim Immune Therapeutics (Zhejiang) Co., Ltd.","INDUSTRY"]