[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ever Supreme Bio Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,66,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100480204","phase-1-evaluate-the-safety-and-efficacy-of-allogeneic-umbilical-cord-mesenchymal-stem-cells-in-patients-with-multiple-sclerosis-100480204",false,"NCT05532943","Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis","A Seamless Phase I\u002FIIa Clinical Study to Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis","UMSC01","Inclusion Criteria:\n\n1. Patients are willing to sign informed consent.\n2. Male or female are age between 20 to 65 years old on date of consent.\n3. Diagnosis of Relapsing-Remitting MS (RRMS) (≥1 clinically documented relapse in the past 12 months, ≥2 clinically documented relapses in the last 24 months or ≥ 1 gadolinium enhanced lesion or T2 new lesion in the last 12 months) or Secondary Progressive MS (SPMS) (EDSS increase ≥1.0 point (baseline EDSS ≤ 5.0) or ≥ 0.5 point (baseline EDSS ≥5.5), and ≥1 clinical relapse or ≥1 gadolinium enhanced lesion in the last 12 months)\n4. MS diagnosis established between 2 to 15 years and EDSS score between 2.0 to 6.5 before enrollment\n5. Patient has appropriated blood clotting function as assessed by the following laboratory requirements: PT, APTT ≤ 1.5X upper limit of normal (ULN).\n6. Treatment failure (either ≥ 1 relapse, ≥ 1 new T2 lesion, ≥ one gadolinium enhanced lesion or EDSS deterioration) with at least one of MS disease modifying therapy as Interferon-β, Glatiramer acetate (Copaxone), Dimethyl fumarate (Tecfidera), Teriflunomide (Aubagio), Fingolimod (Gilenya), Ozanimod (Zeposia), Cladribine (Mavenclad), Siponimod (Mayzent), Ofatumumab (Kesimpta), or Natalizumab (Tysabri) for more than 6 months\n7. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after UMSC01 treatment\n\nExclusion Criteria:\n\n1. Pregnancy, lactation, and those who are not pregnant but did not, or unwilling to, take effective contraceptives measures 4 weeks before and after the treatment.\n2. Patients with uncontrolled diabetes (fasting blood glucose \\> 250 mg\u002FdL)\n3. Patients with inadequate hepatic and renal function: AST and ALT \\> 5X ULN; eGFR \\\u003C 30 mL\u002Fmin.\n4. Patients who are unable to undergo Brain MRI examination for any reason.\n5. Patients who have medical history or current clinically active malignant tumor, peripheral neuropathy, myopathy or other clinically significant neurological diseases that will confound the evaluation of this study.\n6. Patients who have immuno-compromised condition or is with known clinically significantly autoimmune conditions other than MS or is receiving immunosuppressive treatments other than MS treatment within 6 months.\n7. With active infection that required systemic treatment\n8. Patients who are participating in other clinical trials with an investigational product within 1 month.\n9. Patients who were treated with cytotoxic medications during the last 1 month prior to the infusion.\n10. Relapse of MS within1 month before UMSC01 infusion.\n11. With anti-CD20 therapy, such as rituximab\n12. Patients not suitable to participate the trial as judged by the Investigator(s)","ALL","20 Years","65 Years",{"count":21,"type":22},41,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is to identify the safety and efficacy of repeat IV(Intravenous) and IT(Intrathecal) administrations of UMSC01 in patients with MS. While anti-inflammatory drugs are routinely used for the treatment of MS by inhibiting immune responses, their effects on axon remyelination or neuroregeneration are limited. The combined systemic delivery of UCMSCs via intravenous injection and local administration of the cells by IT was to have safety and therapeutic efficacy for patients with MS.",[29],"Multiple Sclerosis","RECRUITING","2025-08-04",{"date":33,"type":34},"2025-08-07","ACTUAL",{"date":36,"type":34},"2023-09-08",{"date":38,"type":22},"2028-10-31",{"name":40,"class":41},"Ever Supreme Bio Technology Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100527678","phase-1-a-safety-and-efficacy-study-of-allogeneic-car-gamma-delta-t-cells-in-subjects-with-relapsedrefractory-solid-tumors-100527678","NCT06150885","A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed\u002FRefractory Solid Tumors","A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects with Relapsed\u002Frefractory Solid Tumors","CAR001","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years\n2. For phase I part, subjects with histologically confirmed diagnosis of solid tumor with expression of PD-L1 ≥ 1% and are relapsed\u002Frefractory to at least two lines of standard-of-care therapy. For phase IIa part, subjects with histologically confirmed diagnosis of TNBC, NSCLC, CRC or GBM with expression of PD-L1 ≥ 1%, and are relapsed\u002Frefractory to at least two lines of standard-of-care therapy.\n3. With at least one measurable lesion as defined by RECIST1.1 (for TNBC, NSCLC or CRC) or RANO (for GBM)\n4. Able to understand and sign the ICF\n5. Have a life expectancy of \\> 12 weeks\n6. ECOG performance status ≤ 1\n7. Recovered from any previous therapy related toxicity to ≤ grade 2 at screening\n8. With adequate renal function: serum creatinine ≤ 1.5 X ULN; eGFR \\> 50 ml\u002Fmin\n9. With adequate liver function: ALT, AST, and ALP ≤ 3X ULN or ≤ 5 X ULN if liver metastases; and total bilirubin ≤ 1.5X ULN or ≤ 3 X ULN if due to Gilbert's disease\n10. With PT and PTT ≤ 1.5X ULN\n11. With adequate hematopoietic function:\n\n    * ANC ≥ 1,000 cells\u002Fμl\n    * Platelets ≥ 75,000 counts\u002Fμl\n    * Total WBC ≥ 2,000 cells\u002Fμl\n    * Hemoglobin ≥ 8 g\u002FdL\n\nExclusion Criteria:\n\n1. Has received any allogeneic cell therapy before screening\n2. With known or suspected to be hypersensitivity to CAR001 or its excipients, such as DMSO or human serum albumin\n3. With more than one kind of active diagnosed primary cancer\n4. With active infection requiring systemic medication\n5. With medical conditions who are receiving systemic steroid therapy \\>10 mg prednisone\u002Fday or equivalent dose, or other immune-suppressants in the past 2 weeks\n6. Has been diagnosed as HIV positive (confirmed by anti-HIV and nucleic acid test)\n7. With acute cardiovascular disease; NYHA classification ≥ 3; or history of myocardial infarction during the past 6 months; or has active uncontrolled arterial hypertension by medical history. Per investigator's judgment, would not make participation appropriate\n8. With historical or current auto-immune diseases, such as rheumatoid arthritis, type I diabetes, psoriasis or systemic lupus erythematosus\n9. Has uncontrolled psychiatric disorder by medical history\n10. Has CNS diseases except GBM or stroke\n11. Has received any investigational therapy from another clinical study within 4 weeks\n12. Inability to undergo radiological assessment, such as MRI or CT for any reason\n13. Has received radiotherapy or chemotherapy within 2 weeks (but palliative radiation therapy (R\u002FT) for pain control are allowed)\n14. Not suitable to participate the trial as judged by the investigator\n15. Female subject of childbearing potential who:\n\n    * Is lactating; or\n    * Has a positive pregnancy test result at eligibility checking; or\n    * Refuses to adopt at least two form of birth control from signing informed consent to 1 year after the last administration of CAR001.\n16. Male subject with a female spouse\u002Fpartner who is of childbearing potential refuses to adopt at least two forms of birth control from signing informed consent to 1 year after the last administration of CAR001.\n\nFor exclusion criteria #15 and #16, acceptable forms of birth control include:\n\n* Established use of oral, injected, or implanted hormonal methods of contraception that have comparable efficacy (failure rate \\\u003C 1 %), for example hormone vaginal ring or transdermal hormone contraception\n* Placement of an intrauterine device or intrauterine system\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps)","18 Years",{"count":53,"type":22},60,[25,26],"This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed\u002Frefractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed\u002Frefractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).",[57],"Solid Tumor","2024-11-29",{"date":60,"type":34},"2024-12-03",{"date":62,"type":34},"2024-09-01",{"date":64,"type":22},"2027-09-30",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":42},"100527455","phase-2-evaluate-the-efficacy-and-safety-of-allogeneic-umbilical-cord-mesenchymal-stem-cells-as-an-add-on-treatment-for-acute-st-elevation-myocardial-infarction-stemi-patients-100527455","NCT06147986","Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients","A Phase IIa, Dose-Escalation Followed by Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients","Inclusion Criteria:\n\n1. Male or female subjects are aged ≥ 20, \\\u003C 76 years old on date of consent\n2. Presence of typical ischemic chest pain within 12 hours after symptoms onset and clinical diagnosis of acute STEMI according to the 2013 American College of Cardiology (ACC) Foundation\u002F American Heart Association (AHA) guideline for the Management of STEMI\n3. Has undergone standard-of-care for STEMI; the immediate reperfusion management should include primary percutaneous coronary intervention (PCI), aspiration thrombectomy and adjunctive antithrombotic therapy within 12 hours after the onset of symptoms\n4. Received successful acute reperfusion therapy (residual stenosis visually \\\u003C 50% and thrombolysis in myocardial infarction flow ≥ 2) with placement of an intracoronary stent and having a patent infarct-related artery suitable for cell infusion to the target area of abnormal wall motion following myocardial infarction\n5. Evidence of LVEF ≥ 30% and \\\u003C 50% diagnosed by echocardiogram\n6. Evidence of stable vital signs prior to IC infusion of UMSC01 (Day 1), defined as no clinical significance of abnormal respiration, afebrile as judged by the investigator, systolic pressure ≥ 90 mmHg and \\\u003C 160 mmHg, heart rate \\> 50\u002Fmin and \\\u003C 110\u002Fmin\n7. Adequate pulmonary function test defined as a force expiratory volume 1 second (FEV1) \\> 50% predicted and peripheral artery oxygen saturation ≥ 95% at room air\n8. Adequate hematopoietic function at the screening and before administration of study medication:\n\n   * Platelets ≥ 100,000 counts\u002FμL.\n   * Hemoglobin ≥ 8 g\u002FdL.\n   * PT, APTT ≤ 1.5X upper limit of normal (ULN).\n9. Has signed and dated informed consent\n10. All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) shown below, for at least 1 year after the last UMSC01 treatment a. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) b. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment c. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject d. Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3): d.1 Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS) d.3 Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository\n\nExclusion Criteria:\n\n1. With cardiogenic shock (defined as systolic blood pressure \\\u003C80mmHg requiring vasopressors, intra-aortic balloon pump(IABP) or extracorporeal membrane oxygenation (ECMO)\n2. Presence of severe aortic stenosis or regurgitation according to the recommendation of the 2020 ACC\u002FAHA guideline for themanagement of patients with valvular heart disease\n3. Presence of severe mitral stenosis or regurgitation according to the recommendation of the 2020 ACC\u002FAHA guideline for the management of patients with valvular heart disease\n4. With a need to undergo staged coronary intervention therapy or coronary artery bypass grafting (CABG) surgery\n5. Under an immuno-compromised condition, with known clinically significantly autoimmune conditions, or receiving immunosuppressive treatments within 12 weeks prior to the study intervention\n6. Presence of any active malignancy that required treatment within 2 years prior to Screening Visit\n7. With ongoing or within the past 2 years serious medical conditions (e.g., concurrent illness), other clinically significant cardiovascular diseases, psychiatric condition (e.g., alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject\n8. With inadequate hepatic and renal function after onset of STEMI: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 4 x upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \\\u003C 40 mL\u002Fmin, calculated by Modification of Diet in Renal Disease equation (MDRD) 175 formula\n9. With uncontrolled diabetes mellitus (blood glucose level \\> 200 mg\u002FdL or HbA1c ≥ 8.5%)\n10. Participation in a clinical trial of an investigational product within 3 months prior to Screening Visit\n11. Known or suspected hypersensitivity or previous adverse reaction to any ingredients of study product\n12. Female subject with child-bearing potential (between puberty and 2 years after menopause) who is pregnant, lactating or has positive urine pregnancy test at Screening Visit\n13. Subjects not suitable to participate the trial as judged by the Investigator(s)","75 Years",{"count":21,"type":22},[26],"This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.",[78],"ST Elevation Myocardial Infarction","2024-09-10",{"date":81,"type":34},"2024-09-19",{"date":83,"type":34},"2023-09-24",{"date":85,"type":22},"2027-06-24",{"name":40,"class":41},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100371391","phase-2-evaluate-the-efficacy-and-safety-of-adcv01-as-an-add-on-treatment-for-primary-glioblastoma-multiforme-gbm-patients-100371391","NCT04115761","Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients","A Phase II, Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Autologous Dendritic Cell Vaccination (ADCV01) As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients","Inclusion Criteria:\n\nStage I (Pre-screening)\n\n1. Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery.\n2. Patients with newly diagnosed single, primary, WHO grade IV, glioblastoma (except for locating on brainstem or cerebellum) scheduled to undergo craniotomy tumor excision, and are willing to preserve the resected tumor cells enabling the production of ADCV01.\n3. Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer).\n4. Only one GBM tumor number.\n5. Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study.\n6. Patients have the expected life expectancy of \\> 12 weeks at the pre-screening visit as judged by the investigator.\n7. Patients with stable vital sign and KPS ≥ 70 at the pre-screening visit.\n8. Patients with adequate renal function at the pre-screening visit:\n\n   serum creatinine \\\u003C 1.8 mg\u002FdL; creatinine clearance \\> 30 mL\u002Fmin\n9. Patients with adequate liver function at the pre-screening visit:\n\n   AST, ALT, and ALP ≤ 3× upper limit of normal (ULN); and total bilirubin \\\u003C 3 mg\u002FdL\n10. Patients with prothrombin time and activated partial thromboplastin time ≤ 1.5× ULN at the pre-screening visit\n11. Patients with adequate hematopoietic function at the prescreening and before administration of study medication\n\n    1. Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FμL\n    2. Platelets ≥ 100,000 counts\u002FμL\n    3. Total white blood cell (WBC) ≥ 2,000 cells\u002FμL\n    4. Hemoglobin ≥ 8 g\u002FdL\n12. All male and female patients with child-bearing potential (between puberty and 2 years after menopause) must be practicing sexual abstinence and be willing to continue to use a medically acceptable form of birth control for at least 1 month prior to screening (that period will extend to 3 months for oral contraceptive use). The patients should use appropriate contraceptive method(s) as shown below, until at least 6 months after the last dose of ADCV01 administration.\n\n    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, thermal symptom post-ovulation methods) and withdrawal are not acceptable methods of ontraception).\n    2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before administration of study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n    3. Male sterilization (at least 6 months prior to screening). For female subjects in the study, the vasectomized male partner should be the sole partner for that subject\n    4. Combination of any two of the following listed methods:\n\n    (d.1+d.2 or d.1+d.3, or d.2+d.3): d.1 Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception. d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n13. Patients agree to be in compliance with treatment plan as planned in the clinical protocol.\n\n    Stage II (Screening\u002FRandomization) In addition to fulfill the criteria in Stage I, following criteria should be met to be eligible for remaining in the study.\n14. Patients' resected brain tumors are pathologically confirmed cases of the IDH-1 wild-type glioblastoma, and patients are willing to do monocyte-collecting apheresis at the screening\u002Frandomization visit.\n15. At the screening\u002Frandomization visit, patients' resected brain tumors are confirmed of low PD-1+\u002F CD8+ ratio (ratio \\\u003C0.21).\n16. Residual tumor with less than 25% contrast-enhancing mass on post-surgical brain MRI (within 2 days post-operation) as assessed by the neurosurgeon and\u002For radiologist.\n\nExclusion Criteria:\n\nStage I (Pre-screening)\n\n1. Number of GBM is more than one\n2. Patient who has participated in other investigational studies within 4 weeks prior to pre-screening\n3. Patient with known or suspected hypersensitivity to ADCV01 or its excipients\n4. Patient who has a history of hypersensitivity reaction (e.g., urticarial, allergic reaction including anaphylaxis, toxic epidermal necrosis, and Stevens-Johnson syndrome) to dacarbazine (DTIC) or any components of medications of temozolomide and bevacizumab\n5. Patient has acute infectious disease or acute cardiovascular disease; clinically manifest myocardial insufficiency or history of myocardial infarction during the past 6 months prior to prescreening; or has active uncontrolled arterial hypertension as supported by medical history.\n6. Patient has clinically significant immuno-compromised condition (other than that related to the use of corticosteroids), is human immunodeficiency virus positive (anti-HIV and nucleic acid test) or medical condition requiring systemic immunesuppressive treatments.\n7. Patient with active rheumatic disease or other collagen vascular disease, or is with active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barre syndrome). Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition, only requiring hormone replacement therapy are permitted to enroll.\n8. Patients with psoriasis requiring systemic therapy, or conditions expected to recur in the presence of an external trigger\n9. Patient with syphilis, acute HBV, HCV (except hepatitis carriers), HTLV-I\u002FII, CMV, or an increased risk (or has been diagnosed) for human transmissible spongiform encephalopathy (TSE); including Creutzfeldt-Jakob disease (CJD)\n10. Patient with history of coagulation disorder associated with bleeding or recurrent thrombotic events\n11. Patient with medical, social, or psychological factors interfering with compliance of the study\n12. Female patient who is lactating, pregnant, or planned to be pregnant\n13. Inability to undergo MRI for any reason\n14. History of malignancy other than glioma that is not stable in the past 5 years prior to pre-screening (informed consent form signing date)\n15. Patient not suitable to participate the trial as judged by the investigator. Stage II (Screening\u002FRandomization)\n\n    The patient will be no longer eligible to participate the study if he\u002Fshe met any of the following criteria:\n16. GBM patients with high PD-1+\u002FCD8+ ratio ≥ 0.21\n17. GBM patients with mutant IDH-1\n18. Residual tumor volume more than 25% of pre-operative tumor size.",{"count":95,"type":22},24,[26],"This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme",[99],"GBM",{"date":81,"type":34},{"date":102,"type":34},"2019-06-06",{"date":104,"type":22},"2026-12-30",{"name":40,"class":41},3,""]