[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nk-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nk-cell":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,75,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100637386","phase-1-a-phase1-clinical-trial-evaluating-locoregional-delivery-of-engineered-nk-cells-containing-il13ra-and-egfviii-chimeric-antigen-receptor-car-il-21-secretion-and-deleted-tgf-betar2-and-nr3c1-in-recurrent-glioblastoma-100637386",false,"NCT07579208","A Phase1 Clinical Trial Evaluating Locoregional Delivery Of Engineered NK Cells Containing IL13Ra And EGFvIII Chimeric Antigen Receptor (CAR), IL-21 Secretion And Deleted TGF-BetaR2 And NR3C1 In Recurrent Glioblastoma","Eligibility Criteria\n\n1. Male or female subjects aged ≥ 18 years.\n2. Histologically confirmed supratentorial 2021 World Health Organization recurrent glioblastoma (IDH-wildtype GBM), gliosarcoma, or recurrent IDH-mutant WHO grade 4 astrocytoma, with any prior number of recurrences.\n3. Have received prior radiation and temozolomide therapy.\n4. Single tumor no larger than 5 cm in its greatest diameter.\n5. Karnofsky Performance Status (KPS) score of \\>70.\n6. Has a baseline brain MRI obtained no more than 30 days prior to NK cell infusion\n7. Adequate hematological function defined by white blood cell (WBC) count ≥ 3 x 10\u002FL with absolute neutrophil count (ANC) ≥1.5 x109\u002FL, lymphocyte count ≥ 0.5 x 109\u002FL, platelet count ≥ 100 x 109\u002FL, and Hgb ≥ 9 g\u002F dL (in absence of blood transfusion).\n8. Adequate hepatic function defined by a total bilirubin level . 1.5 \\~ ULN, an AST level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN, and INR ≤ 1.5.\n9. Adequate renal function defined by creatinine ≤ 1.5 X upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 X institutional ULN.\n10. Female subject of childbearing potential should have a negative serum pregnancy test. Subjects and their partners must be willing to use effective birth control during the study and for up to 3 months following last administration of NK cells. .\n11. Prior Avastin use is allowed after at least a 12-week washout period.\n12. Agree to sign consent to the long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.\n\nExclusion Criteria\n\n1. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.\n2. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks since last dose of agent administration.\n3. Has known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v5.0), any history of anaphylaxis, within 5 months.\n4. Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1\u002F2 antibodies); HTLV1 and\u002For HTLV2; active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Participants with prior HBV vaccination (anti-HBs positive, HBsAg negative, anti-HBc negative) will NOT be excluded.\n5. Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy (such as tacrolimus, cyclosporine, infliximab) within 7 days prior to study registration.\n6. Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent such as thrombocytopenia or platelets toxicity. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study at the discretion of the treating investigator.\n7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include superficial tumors considered adequately treated locally with curative intent, including but not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Any exceptions must be discussed with the protocol PI.\n8. Has known Gliomatous meningitis or extracranial disease, or tumor localized primarily to the brainstem or spinal cord\n9. Midline shift greater than 0.5 cm or pending herniation\n10. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants receiving epidural steroid injections for pain will be excluded. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n11. Has evidence of interstitial lung disease or active, non-infectious pneumonitis\n12. Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the subject's participation, assessment of experimental treatment toxicity or increase the subject's risk of side effects\n13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate in the opinion of the treating investigator.\n14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment\n16. Has received a live vaccine within 30 days prior to the first dose of trial treatment\n17. Has a contraindication for undergoing MRIs\n18. Has evidence of bleeding diathesis or coagulopathy\n19. Is on full dose anticoagulants or antiplatelet therapy that cannot be held (full dose depends on the actual anticoagulant)\n20. Has significant hemorrhage on baseline scan defined as \\>1 cm diameter of acute blood\n21. Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant)\n22. Has multifocal disease. Subject has multifocal GBM, defined as discrete sites of contrast enhancing disease without contiguous T2\u002FFLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2\u002FFLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.","ALL","18 Years",{"count":18,"type":19},36,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To find the best method of administering NK cells in patients with recurrent glioblastoma.",[25,26,27,28,29,30,31],"Phase 1","NK Cell","IL13Ra","EGFRvIII","Chimera Antigen Receptor (CAR)","NR3C1","Recurrent Glioblastoma","NOT_YET_RECRUITING","2026-05-06",{"date":35,"type":36},"2026-05-12","ACTUAL",{"date":38,"type":19},"2026-10-24",{"date":40,"type":19},"2030-07-30",{"name":42,"class":43},"M.D. Anderson Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100580272","phase-1-cd123-cd16-nk-cells-immunotherapy-for-aml-100580272","NCT06835140","CD123-CD16-NK Cells Immunotherapy for AML","CD123-Targeted CD16 Antibody-Modified NK Cell Immunotherapy for Refractory\u002FRelapsed Acute Myeloid Leukemia (R\u002FR AML)","CD123-CD16-NK","Inclusion Criteria:\n\n1. Age: Between18 years and 70 years.\n2. Diagnosis and Treatment History:\n\n   Diagnosed with Acute Myeloid Leukemia (AML) in the hospital. Has undergone multiple first-line clinical treatments and has developed resistance to current treatments. Relapse after original induction therapy failure with a predicted survival of more than three months.\n3. CD123 Expression:\n\n   Flow cytometry detection shows CD123-positive AML cells.CD123 expression level is not less than 20%.\n4. Hospital Examination Criteria:\n5. Performance Status:\n\n   ECOG Performance Status score of 0-2 or Karnofsky Performance Status (KPS) score greater than 80.\n6. Donor Availability:\n7. Have a suitable healthy donor and agree to peripheral blood collection.\n\nExclusion Criteria:\n\n1. Specific AML Subtype:\n\n   Diagnosed with Acute Promyelocytic Leukemia(APL).\n2. CD123 Expression:\n\n   Flow cytometry shows CD123 negative or CD123 expression level less than 20%.\n3. Prior Treatment Toxicity:\n\n   Persistent non-hematologic toxicity of grade 2 or higher related to previous treatments.\n4. GVHD Requiring Immunosuppression:\n\n   Patients requiring immunosuppressants for grade II-IV acute Graft-Versus-Host Disease (GVHD).\n5. Recent Steroid Treatment:\n\n   Systemic steroid treatment within 7 days prior to first study drug treatment (excluding topical and inhaled corticosteroids or short-term prophylactic steroid treatment).\n6. Severe Cardiovascular and Cerebrovascular Diseases:\n\n   Certain cardiovascular and cerebrovascular diseases within 6 months prior to first dose.\n\n   New York Heart Association (NYHA) classification ≥3 or uncontrolled malignant arrhythmias.Other cardiovascular and cerebrovascular diseases deemed unsuitable by the investigator.\n7. Pregnancy and Lactation:\n\n   Pregnant or breastfeeding women (the safety of this treatment for unborn babies is unknown).\n\n   For female participants, pregnancy must be confirmed negative by serum or urine pregnancy test within 48 hours before infusion.\n8. Infections:\n\n   Active Hepatitis B,Hepatitis C virus infection, Peripheral blood CMV-DNA ≥500 copies\u002FmL, HIV\u002FAIDS infection and any uncontrolled active infection.\n9. Allergic Reactions:\n\n   Allergic to immunotherapy and related drugs.\n10. Neurological Diseases:\n\nNeurological diseases such as neurodegenerative diseases, primary central nervous system tumors\u002Finfections, multiple sclerosis, epilepsy, severe peripheral neuropathy, etc.","70 Years",{"count":55,"type":19},9,[22],"The goal of this clinical trial is to evaluate the effectiveness of CD123-CD16 bispecific antibody-modified NK cells in treating patients with CD123-positive relapsed or refractory Acute Myeloid Leukemia (RR AML). It will also assess the safety of this modified NK cell therapy.\n\nThe main questions： Does the infusion of CD123-CD16 bispecific antibody-modified NK cells induce remission in RR AML patients? What are the safety and potential adverse effects associated with the administration of these modified NK cells? Researchers will administer CD123-CD16 bispecific antibody-modified NK cells to RR AML patients and compare the outcomes to existing treatment options to determine efficacy and safety.\n\nParticipants will:\n\nUndergo lymphocyte-depleting chemotherapy Fludarabine\\&Cyclophosphamide from day -5 to day -3 before NK cell infusion.\n\nReceive intravenous infusions of modified NK cells at escalating doses:\n\nThe first three patients will receive 1×10⁷ cells\u002Fkg. The next three patients will receive 2×10⁷ cells\u002Fkg. The final three patients will receive 4×10⁷ cells\u002Fkg. Have NK cell infusions administered every 96-120 hours for a total of three infusions, with each infusion completed within 10 to 15 minutes.\n\nUndergo dose escalation with subsequent groups only after confirming the safety of the previous dose group.\n\nHave their vital signs (temperature, heart rate, respiratory rate, blood pressure, etc.) monitored before and after each infusion.\n\nKeep baseline data records during NK cell infusions. Participate in follow-up assessments to monitor disease remission and detect any adverse events.\n\nThis trial aims to provide new treatment options for RR AML patients by leveraging the targeted cytotoxic effects of CD123-CD16 bispecific antibody-modified NK cells to achieve disease remission.",[59,26,60],"AML (Acute Myelogenous Leukemia)","CD123+ Acute Myeloid Leukemia",[62,63,64],"CD123-CD16 bispecific antibody","NK cell","Refractory\u002Frelapsed AML","RECRUITING","2025-02-23",{"date":68,"type":36},"2025-02-25",{"date":70,"type":19},"2025-02-21",{"date":72,"type":19},"2025-12-31",{"name":74,"class":43},"Chunji Gao",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":20,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100565397","phase-1-a-phase-i-single-arm-clinical-study-of-donor-nk-cells-infusion-combined-with-low-dose-interleukin-2-in-the-treatment-of-acute-myeloid-leukemia-relapse-after-allogeneic-hematopoietic-stem-cell-transplantation-100565397","NCT06641648","A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined with Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n* 1.Age ≥ 18 years old, no gender or race; 2.Expected survival period ≥ 3 months; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; 4.The diagnosis of AML who received allo-HSCT, and met the following criteria: A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment; C. Degree II and above acute graft-versus-host disease did not occur after transplantation; D. Available allogeneic hematopoietic stem cell transplant donors. 5. Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL\u002Fmin; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 45%; 6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; 7. Informed Consent\u002FAssent: All subjects must have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Central nervous system involved; 2. Patients who received the following anti-tumor therapies prior to infusion: A. Systemic use of hormones within 3 days prior to infusion (except for patients with inhaled corticosteroids); B. Systemic anti-tumor therapy within 2 weeks or within 5 drug half-lives (whichever is shorter); C. Radiotherapy within 4 weeks; D. DLI within 6 weeks; E. Intrathecal injection within 1 week; F. Received CAR-T, CAR-NK or other modified cell therapy within 6 months; 3. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.\n\n  4\\. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; 5. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; 6. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating; 7. Suffering from a serious autoimmune disease or immunodeficiency disease; 8. Known alcohol dependence or drug dependence; 9. According to the investigator\\'s judgment, the patient has other unsuitable grouping conditions.",{"count":82,"type":19},12,[22],"This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[86,87,26],"Acute Myeloid Leukemia (AML)","Acute Myeloid Leukemia (AML) Relapse",[89,90,91,63],"AML","relapse","allogeneic hematopoietic stem cell transplantation.","2024-10-11",{"date":94,"type":36},"2024-10-15",{"date":96,"type":19},"2024-12-01",{"date":98,"type":19},"2026-06-30",{"name":100,"class":43},"Peking University First Hospital",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":20,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":44},"100509105","phase-1-safety-and-efficacy-of-autologous-nk-cell-adjuvant-therapy-for-relapsedrefractory-non-hodgkins-b-cell-lymphoma-100509105","NCT05909098","Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed\u002FRefractory Non-Hodgkin's B-cell Lymphoma","Xiangyang No.1 People's Hospital, Hubei University of Medicine","Inclusion Criteria:\n\n1. Patients with age 15 years to 80 years, with life expectancy greater than 6 months.\n2. Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.\n3. First diagnosed relapsed\u002Frefractory non-Hodgkin's B-cell lymphoma.\n4. ECOG scores were 0 to 2\n5. Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.\n6. For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years.\n7. For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.\n8. Volunteer to participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Presence of bone marrow or\u002Fand central nervous system lymphoma.\n2. Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.\n3. Combined with other malignancies.\n4. Fever of non-disease-related origin within the last 5 days.\n5. Presence of uncontrollable bacterial, fungal, viral or other infections.\n6. Patients with HIV, TP positive\n7. Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present.\n8. Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc.\n9. Received any form of organ transplantation, including allogeneic stem cell transplantation.\n10. Presence of a serious psychiatric disorder.\n11. Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment.\n12. Pregnant or lactating women.\n13. The researchers deemed unsuitable for participation in this study. -","80 Years",{"count":110,"type":19},33,[22,112],"PHASE2","This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed\u002Frefractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed\u002Frefractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.",[26,115,116],"B-cell Lymphoma Recurrent","B-cell Lymphoma Refractory","2023-06-19",{"date":119,"type":36},"2023-06-22",{"date":121,"type":19},"2023-07-01",{"date":123,"type":19},"2028-11-30",{"name":125,"class":43},"Xiangyang No.1 People's Hospital","NK-Cell"]