[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-meningioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-meningioma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100635403","nk-cell-therapy-for-malignant-solid-brain-tumors-100635403",false,"NCT07552233","NK Cell Therapy for Malignant Solid Brain Tumors","NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors","Inclusion Criteria:\n\n1. Male or female, age 18-70 years old (both ends included)\n2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment\n3. Karnofsky Performance Status (KPS) ≥ 60%\n4. Life expectancy \\> 4 weeks, and must be able to undergo an MRI with contrast\n5. Patients who completed radiotherapy or systemic therapies (including temozolomide\u002Fbevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)\n6. Dexamethasone dose ≤ 4 mg\u002Fday or equivalent corticosteroid dose, or no dexamethasone administered\n7. Must have adequate organ and marrow function as defined below:\n\n   * White blood cell count (WBC) ≥ 3 x 10\\^9\u002FL\n   * Absolute neutrophil count (ANC) \\> 1 x 10\\^9\u002FL\n   * Hemoglobin (Hb) ≥ 90 g\u002FL\n   * Platelet (PLT) ≥ 80×10\\^9\u002FL\n   * Albumin transaminase (ALT) \\& albumin transaminase (AST) \\\u003C 1.5 × institutional upper limit of normal (ULN)\n   * Serum creatinine (Cr) \\\u003C 1.5 x institutional ULN\n   * Total bilirubin \\\u003C 1.5 x institutional ULN\n   * PT \\& PTT ≤ 1.25 x institutional ULN\n8. No obvious hereditary diseases\n9. Normal cardiac function with left ventricular ejection fraction \\>55%\n10. No bleeding and coagulation disorders\n11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and\u002For there aren't any indications of meningitis\n12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n13. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Active hepatitis B or C virus, HIV infection, or other untreated active infection\n2. Pregnant and lactating women\n3. Participants with organ failure\n4. Participants with a chronic disease requiring immunologic or hormonal therapy\n5. Participants with an allergy to immunotherapy and related cells\n6. Participants with uncontrolled intercurrent illness\n7. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n8. Participants with a history of organ transplantation or who are awaiting organ transplantation","ALL","18 Years","70 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of the immunological effects of NK cell infusion in the tumor microenvironment and peripheral blood.",[27,28,29,30,31],"Malignant Solid Brain Tumors","Glioblastoma (GBM)","Glioblastoma Multiforme (GBM)","Brain Metastasis","Malignant Meningioma",[27,33,34,35],"Immunotherapy","Natural Killer Cell","NK Cell","RECRUITING","2026-04-20",{"date":39,"type":40},"2026-04-27","ACTUAL",{"date":42,"type":21},"2026-04",{"date":44,"type":21},"2030-12-31",{"name":46,"class":47},"Peking University Third Hospital","OTHER",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100606178","early-phase-1--t-pd-1-ab-cells-in-the-treatment-of-malignant-meningioma-100606178","NCT07172178","γδ T-PD-1 Ab Cells in the Treatment of Malignant Meningioma","Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Malignant Meningioma, a Phase I Clinical Trail","Inclusion Criteria:\n\n1. The patient voluntarily signs the informed consent and can complete the follow-up examination, evaluation and treatment;\n2. Age 18-70 years old (both ends included), both male and female;\n3. The histopathological diagnosis was malignant solid tumor;\n4. Tumor recurrence is confirmed by imaging (MRI) or re-biopsy\u002Fsurgery;\n5. ECOG score 0-2;\n6. Expected survival ≥6 months;\n7. Have received chemotherapy or targeted therapy more than 4 weeks ago;\n8. Organ function requirements:\n\n   Bone marrow function: white blood cell count≥3×109, platelets ≥70×109\u002FL, a hemoglobin (Hb) ≥90g\u002FL; Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; Renal function: serum creatinine level ≤1.5 ULN; Coagulation function: international normalized ratio (INR) does not exceed 1.5 times the upper limit of normal, and activated partial thromboplastin time (APTT) does not exceed 1.5 times the upper limit of normal.\n\n   Cardiac function: left ventricular ejection fraction (LVEF) \\> 55%\n9. Pregnant women of childbearing age must have a negative serum pregnancy test within 28 days before treatment. Any fertile male and female patients must agree to use effective contraceptive methods throughout the study and for at least 12 weeks after the last study administration.\n\nExclusion Criteria:\n\n1. Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;\n2. Major organ dysfunction:\n\n   Cardiac function: Left ventricular ejection fraction (LVEF) ≤ 55%, New York Heart Association (NYHA) grade III or IV congestive heart failure, QTc \\> 480 msec, other cardiac diseases as determined by the investigator to be unsuitable for inclusion.\n\n   Liver function: Child-Pugh liver function classification C or above. Pulmonary function: Severe respiratory failure affecting other organs.\n3. Uncontrolled epilepsy, severe bleeding risk (such as a recent history of cerebral hemorrhage).\n4. Active and\u002For uncontrolled infections (such as tuberculosis, sepsis, opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, Treponema pallidum (TP) infection).\n5. Severe, uncontrolled systemic autoimmune or inflammatory diseases (such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis, Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)).\n6. Unstable systemic diseases: unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), grade III or IV cardiac dysfunction, refractory hypertension (refractory hypertension is defined as: after lifestyle improvement and using appropriate doses of ≥ 4 antihypertensive drugs (including diuretics), blood pressure cannot be effectively controlled after treatment for more than 1 month and still not controlled), severe arrhythmia requiring drug treatment, hepatic arrhythmia, liver disease, kidney disease or metabolic disorders.\n7. Patients with other malignant tumors.\n8. Major surgeries within 4 weeks before screening that were assessed by the investigator as unsuitable for inclusion.\n9. Participated in other interventional clinical studies within 30 days before enrollment.",{"count":57,"type":21},12,[59],"EARLY_PHASE1","This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of malignant meningioma.",[31],"NOT_YET_RECRUITING","2025-09-11",{"date":65,"type":40},"2025-09-15",{"date":67,"type":21},"2025-10-15",{"date":69,"type":21},"2029-10",{"name":71,"class":47},"Nanjing Medical University"]