[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroblastoma-recurrent-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroblastoma-recurrent-refractory":21},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,38,72],{"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":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":35,"locationsCount":4},"100583143","expanded-access-protocol-for-the-use-of-sl-28-in-the-treatment-of-advanced-solid-tumors-100583143",false,"NCT06872489","Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;\n* Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n* For patients with relapsed\u002Frefractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;\n* ECOG Performance Status from 0 or 3;\n* The expected survival time is more than 12 weeks;\n* 2 to 65+ old, gender is not limited;\n* The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;\n* Be able to comply with trial and follow-up procedures;\n* Adequate bone marrow and organ function;\n* Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);\n* Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.\n* The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;\n* For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.\n* Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;\n* Radiation therapy: 60 days should have elapsed in the case of completing radiation.\n* Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.\n\nExclusion Criteria:\n\n* Untreated or active primary central nervous system (CNS) tumor or metastasis;\n* Patients diagnosed of having primary and secondary immunodeficiencies;\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Arterial\u002Fvenous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known allergy to any of the agents or their ingredients used in this study;\n* Patients who are on hemodialysis;\n* Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n* Patients with untreated positive blood cultures or progressive infections.","ALL","2 Years","EXPANDED_ACCESS","This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.\n\nResearchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.\n\nSL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.",[20,21,22,23,24,25,26,27,28,29],"Neuroblastoma in Children","Neuroblastoma, Recurrent, Refractory","Advanced Cancer","Advanced Malignant Neoplasm","Prostate Cancer Patients With Bone Metastasis","Lung Cancer Non-Small Cell Cancer (NSCLC)","Lung Cancer - Non Small Cell","Gastrointestinal Cancers","Head and Neck Cancer","Pancreatic Cancer","AVAILABLE","2025-07-17",{"date":33,"type":34},"2025-07-23","ACTUAL",{"name":36,"class":37},"Second Life Therapeutics","INDUSTRY",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100567905","phase-1-safety-and-efficacy-of-systemic-allogenic-nk-cells-in-rr-neuroblastoma-100567905","NCT06674265","Safety and Efficacy of Systemic Allogenic NK Cells in R\u002FR Neuroblastoma","Evaluation of Safety and Efficacy Evaluation Post Intravenous Infusion of Activated NK Cells in Recurrent and Refractory High-risk Neuroblastoma Patients","Inclusion Criteria:\n\n1. High-risk neuroblastoma that is resistant to standard induction therapy based on COG (Children's Oncology Group) criteria (according to INRG criteria and having received at least 4 cycles of multi-drug induction chemotherapy, and not responding to conventional treatments).\n2. Evidence of relapse or progression of neuroblastoma after autologous peripheral blood stem cell transplantation or aggressive therapy.\n3. A minimum life expectancy of 6 months.\n4. Patients must have a pathological diagnosis of neuroblastoma and\u002For confirmation of tumor cells in the bone marrow with increased urinary catecholamines.\n5. Measurable residual disease based on imaging findings using Curie scoring or MIBG or PET imaging criteria (1: measurable tumor of at least 10 mm in one dimension on MRI or CT scan with positive uptake on I-123 MIBG scan (\"MIBG avid\") oOR 2): increased FDG uptake on 18F-FDG PET-CT or PET-MRI (\"PET avid\")).\n\n   \\-\n\nExclusion Criteria:\n\n1. Insufficient bone marrow function: Platelet count \\> 50,000\u002FµL, independent of transfusion (no platelet transfusion within one week). Absolute neutrophil count (ANC) maximum of 500 per microliter. Hemoglobin \\> 10 grams per deciliter.\n2. Insufficient liver function: Plasma bilirubin level more than 1.5 times the upper limit of normal (ULN). SGPT (ALT) at least three times the upper limit of normal (a level of 45 units per liter is considered the upper limit of normal).\n3. Insufficient kidney function: Creatinine clearance or estimated radioisotope GFR \\\u003C 70 ml\u002Fmin\u002F1.73m². Plasma creatinine level more than 1.5 times the upper limit of normal based on age\u002Fgender.\n4. Insufficient central nervous system function if seizures are present, entry into the study is not possible and if seizures are not well controlled with anticonvulsant drugs.\n\n3- Insufficient cardiovascular function Shortening fraction \\\u003C 27% by ECHO OR Ejection fraction \\\u003C 50% by ECHO or gated radionuclide study.\n\n4- Insufficient pulmonary function evidence of dyspnea at rest. Exercise intolerance. Chronic need for oxygen and room air pulse oximetry \\\u003C 94% if pulse oximetry evaluation is clinically indicated. Presence of current pleural or pericardial effusion.\n\n5- Inability to tolerate new treatment due to emergency conditions. 6- Elevated catecholamines (more than twice the ULN) or sole involvement of bone marrow (bone marrow positive for NB as the only evaluable disease without confirmatory pathology report).\n\n7- Receiving 0.5 mg\u002Fkg\u002Fday of systemic steroids (equivalent to prednisone) for at least 7 days before enrollment.\n\n8- Receiving CYP3A4 inducers or inhibitors at least 7 days before study enrollment.\n\n9- Diagnosis of any other malignancy alongside the diagnosis of neuroblastoma. 10- Diarrhea \\> Grade 2 (4 to 6 stools per day). 11- Significant illness not covered by exclusion criteria but interfering with the study process or increasing the intensity of treatment with NK cells.\n\n12- Participation in another clinical trial. 13- Severe impairment of major organ functions, such as renal, cardiac, hepatic, neurological, pulmonary, or gastrointestinal toxicity above Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTC v5.0).\n\n14- Inability to comply with protocol requirements. 15- Lack of confirmed and signed consent by the patient's guardians. 16- Evidence of HIV disease (Human Immunodeficiency Virus) or positive serology for HIV.","16 Years",{"count":47,"type":48},10,"ESTIMATED","INTERVENTIONAL",[51],"PHASE1","The goal of this clinical trial is to assess safety and efficacy of systemic injection of allogenic NK cells in patients with refractory\u002Frecurrent high-risk neuroblastoma.\n\nIs the injection of allogenic nk cells safe in patients with R\u002FR high-risk neuroblastoma? Is the injection of allogenic nk cells effective in patients with R\u002FR high-risk neuroblastoma? We will compare the NK cell administration group with a control group that receives conventional treatment to determine whether the intervention is safe and effective",[21,54,20],"Neuroblastoma (NB)",[56,57,58,59,60],"Neuroblastoma","High-Risk Neuroblastoma","Natural Killer Cell","Nk Cell","adrenal gland","RECRUITING","2025-04-05",{"date":64,"type":34},"2025-04-09",{"date":66,"type":34},"2024-11-10",{"date":68,"type":48},"2026-11",{"name":70,"class":37},"Marzieh Ebrahimi",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":49,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100573811","phase-1-chimeric-natural-killer-receptor-universal-t-cells-for-relapsed-or-refractory-neuroblastoma-100573811","NCT06751134","Chimeric Natural Killer Receptor-Universal T Cells for Relapsed or Refractory Neuroblastoma","A Study to Evaluate the Safety, Preliminary Efficacy, Pharmacokinetics of CNK-UT Cells to Treat the Patients with Relapsed\u002Frefractory Neuroblastoma","Inclusion Criteria:\n\n1. Aged 1-12 years with weight≥10kg, male or female;\n2. The child and\u002For guardian has signed the informed consent form (ICF) and has the ability to comply with the study requirements.\n3. Diagnosed with relapsed\u002Frefractory neuroblastoma. Clinical diagnostic criteria and first-line standard treatment can refer to the NCCN guidelines:\n\n   1. Relapsed neuroblastoma: New lesions appear at the primary site or other locations 4 weeks after achieving complete remission through first-line standard treatment.\n   2. Refractory neuroblastoma: Failure to achieve complete remission after standard treatment protocols, which include induction chemotherapy, surgery, and radiotherapy targeting the primary tumor and residual metastatic sites;\n4. Prior to enrollment, appropriate measures can be implemented to ensure that the subject's disease status is either partial remission (PR) or stable disease (SD).\n5. According to the INRC efficacy criteria, there must be at least one lesion whose efficacy can be assessed through functional imaging (123I-MIBG) and\u002For bone marrow examination (bone marrow aspiration or biopsy). If soft tissue lesions are present, the longest diameter of the target lesion should be ≤2 cm.\n6. Tumor tissue sections or paraffin blocks can be provided, and it has been confirmed through immunohistochemistry (IHC) that the tumor tissue expresses B7-H3.\n7. Lansky score\\>60；\n8. Estimated life expectancy \\> 12 weeks;\n9. Adequate organ and bone marrow function, and the laboratory test value meets the following requirements within 7 days before enrollment, as follows:\n\n(1)Blood Routine Test: Absolute neutrophil count(ANC)≥1.5×10\\^9\u002FL;Absolute lymphocyte count (ALC)≥0.2×10\\^9\u002FL；Platelet count ≥75×10\\^9\u002FL; Haemoglobin≥90g\u002FL; (2)Heart: Left ventricular ejection fraction (LVEF)≥50%;Cardiac function Grade I-II; (3)Pulmonary function: indoor oxygen saturation≥92%. (4)Hepatic function：Total bilirubin≤3×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)≤5×ULN; (5)Renal function: Serum creatinine≤2×ULN, or Creatinine clearance rate (CCR)≥60 mL\u002Fmin (Cockroft-Gault formula); 10.All toxic responses originating from previous radiotherapy, chemotherapy, or other treatments (occurring within 4 weeks or 5 half-lives of anti-tumor drugs therapy \\[including but not limited to chemotherapy, targeted therapy, immunotherapy, Chinese herbal medicine\\]) have returned to NCI CTCAEV5.0 Grade≤1 (except for hair loss).\n\nExclusion Criteria:\n\n1. Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and \u002F or radical resection of carcinoma in situ.\n2. Participants with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination.\n3. Participants with MIBG non-avid disease.\n4. Participants with a history of organ transplantation（excluding stem cell transplantation）;\n5. Participants with active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) are considered. The use of replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is permitted. A known history of primary immunodeficiency is also noted. For patients who only test positive for autoimmune antibodies, the presence of autoimmune disease must be confirmed based on the investigator's judgment.\n6. Uncontrolled or irreparable systemic diseases, metabolic disorders, or other non-malignant organ diseases or cancer sequelae, which may lead to higher medical risks and\u002For uncertainties in survival assessment.\n7. Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis infection.\n8. Severe infections that are either active or poorly controlled clinically within 4 weeks prior to enrollment, including but not limited to hospitalization due to infections, bacteremia, or severe pneumonia complications (excluding mild urinary tract infections and upper respiratory tract infections).\n9. Received radiotherapy, chemotherapy (excluding lymphodepletion), molecular targeted therapy, immune checkpoint inhibitors, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before cell infusion..\n10. Participants who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the initiation of the study, or have severe unhealed wounds, ulcers, or fractures.\n11. Participants who have received treatment from other clinical trials within 4 weeks prior to the initiation of the study.\n12. Participants who receive attenuated live vaccines within 4 weeks prior to the initiation of the study.\n13. Participants who have used any gene therapy products prior to cell infusion.\n14. Allergic to components of CNK-UT injection.\n15. Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.\n16. Participants considered by the investigator to have other potentially life-threatening serious complications that may interfere with the evaluation of this study..\n17. Other situations that the participant is identified by the investigator as unsuitable to participate in the study.","1 Year","12 Years",{"count":82,"type":48},12,[51],"This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, preliminary efficacy, pharmacokinetics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with relapsed\u002Frefractory Neuroblastoma.",[21],[87],"Chimeric natural killer receptor universal T-cells, relapsed\u002Frefractory Neuroblastoma","2025-02-06",{"date":90,"type":34},"2025-02-07",{"date":92,"type":34},"2024-12-28",{"date":94,"type":48},"2026-12-01",{"name":96,"class":97},"Nanjing Children's Hospital","OTHER",2]