[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroblastoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroblastoma-metastatic":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"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":26,"conditions":27,"keywords":38,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100632820","phase-1-phase-i-clinical-trial-of-thinkk-adoptive-immunotherapy-after-allogeneic-hematopoietic-transplantation-in-children-with-leukemia-or-neuroblastoma-100632820",false,"NCT07518654","Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma","Phase I Clinical Trial of Therapeutic Inducers of Natural Killer Killing (ThINKK) Adoptive Immunotherapy: Feasibility, Safety and Pharmacodynamics in Children Undergoing Allogenic Hematopoietic Transplantation for Leukemia or Neuroblastoma","ThINKK-01","Inclusion Criteria:\n\n1. Between 2 and less than 13 years old at time of informed consent form signature.\n2. Diagnosis of acute leukemia or neuroblastoma.\n3. Allogenic hematopoietic stem cell transplantation 30 to 90 days prior to eligibility confirmation.\n4. Blood NK cell counts ≥ 100 x 10E+6 cells\u002FL at least once before eligibility confirmation.\n5. Life expectancy of ≥ 3 months per investigator's judgment at time of eligibility confirmation.\n6. Patient or legally acceptable representative has provided informed consent based on local regulations and\u002For guidelines prior to any study-specific activities\u002Fprocedures being initiated.\n\nExclusion Criteria:\n\n1. Current grade 3 or 4 acute GvHD (per MAGIC criteria).\n2. Relapse of primary malignancy, or any other active malignancy.\n\n   1. For leukemia, defined as either morphological relapse or Minimal Residual Disease (MRD) ≥0.01% as measured by flow cytometry. MRD detected by polymerase chain reaction (PCR) does not constitute an exclusion criterion.\n   2. For neuroblastoma, defined as a progressive disease.\n3. Ongoing therapy with systemic corticosteroids (equivalent to a prednisone dose \\>0.5 mg\u002Fkg\u002Fday). Patients actively undergoing corticosteroid tapering during Screening may be enrolled once they have reached a prednisone-equivalent dose ≤ 0.5 mg\u002Fkg\u002Fday with Sponsor-Investigator approval, with the expectation that the taper will continue.\n4. Ongoing systemic therapy with cyclosporine.\n5. Administration or planned administration of any prohibited treatment listed in ad hoc section.\n6. Aspartate aminotransferase and alanine aminotransferase serum levels ≥5 times the upper limit of normal.\n7. Direct bilirubin serum levels ≥3 times the ULN (unless due to Gilbert syndrome).\n8. Baseline estimated glomerular filtration rate \\\u003C 50 mL\u002Fmin\u002F1.73 m2, as determined using the Bedside Schwartz equation for \\\u003C 18 years of age.\n9. Grade 4 diarrhea (ie, life-threatening consequences with urgent intervention indicated).\n10. O2 Sat saturation \\\u003C90% on room air by pulse oximetry.\n11. Uncontrolled life-threatening symptomatic infection(s).\n12. Blood pressure below the 5th percentile for age, sex, and height last 24 hours.\n13. Ongoing therapy with intravenous vasopressor agent.\n14. Any condition that, in the opinion of the Investigator, would compromise the safety of the patient, would prevent full participation in this study, or would interfere with the evaluation of any study endpoints.\n15. Pregnancy or breastfeeding or absence of highly effective methods of contraception for males and females of childbearing potential who engage in heterosexual intercourse","ALL","2 Years","12 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse.\n\nThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.",[28,29,30,31,32,33,34,35,36,37],"Leukaemia (Acute Lymphoblastic)","Leukaemia (Acute Myeloid)","Neuroblastoma","Neuroblastoma, Metastatic","Leukaemia, Lymphoblastic, Acute","Leukemia Acute Myeloid","Leukemia (Both ALL and AML)","Leukemia Acute Myeloid - AML","Hematopoetic Stem Cell Transplantation","Hematopoetic Stem Cell Transplant",[39,40,41,42],"Thinkk","NK cells","pdc","immunotherapy","NOT_YET_RECRUITING","2026-04-02",{"date":46,"type":47},"2026-04-08","ACTUAL",{"date":49,"type":22},"2026-05-01",{"date":51,"type":22},"2029-05-01",{"name":53,"class":54},"Michel Duval","OTHER",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":78,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100462046","phase-1-anti-ny-eso-1-tcr-gene-engineered-lymphocytes-given-by-infusion-to-patients-with-ny-eso-1--expressing-metastatic-cancers-100462046","NCT05296564","Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor (TCR)-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","Inclusion Criteria:\n\n1. Have histologically or cytologically confirmed diagnosis of neoplasia\n2. Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory\u002Frecurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth has been documented since local treatment completion.\n3. The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass more than 10% of tumor section.\n4. Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting.\n5. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n6. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).\n7. Age ≥ 18 years and ≤ 70 years.\n8. Patient is able to understand and willing to sign a written informed consent.\n9. Clinical performance status of ECOG 0, 1 or 2.\n10. HLA-A\\*0201or A\\*0206 positive.\n11. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.\n12. Women of child-bearing potential must have a negative pregnancy test.\n13. Serology: Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n14. Hematology\n\n    * ANC \\> 1500\u002Fmm3 without the support of filgrastim\n    * WBC ≥ 3000\u002Fmm3\n    * Platelet count ≥ 100,000\u002Fmm3\n    * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n15. Chemistry\n\n    * Serum ALT\u002FAST ≤ 2.5 x ULN\n    * Creatinine clearance ≥40ml\u002Fmin\n    * Total bilirubin ≤ 1.5 mg\u002FdL, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    * INR \\\u003C 1.5\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n3. Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses\n4. Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention.\n5. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n6. Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n7. Subjects unable to maintain normal oxygen saturation level in room air.\n8. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria:\n\n   * Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis).\n   * Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days or are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n9. Has a known additional malignancy within the last 3 years. Exceptions include early stage cancers (carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy).\n10. LVEF ≤ 40%\n11. Documented FEV1 ≤ 60% predicted tested in patients with:\n\n    * A prolonged history of cigarette smoking (≥ 20 pack-year smoking history, with cessation within the past two years).\n    * Symptoms of respiratory dysfunction.\n12. Patients who are at the time of study initiation receiving any other investigational agents.\n13. Carcinomatosis meningitis or other brain involvement exceeding that allowed above.\n14. Has received live vaccine within 30 days before the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.","18 Years","70 Years",{"count":65,"type":22},3,[25,67],"PHASE2","A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of HBI 0201-ESO TCRT (anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes) Given by Infusion to Patients with NY-ESO-1 -Expressing Metastatic Cancers",[70,71,72,73,74,75,76,31,77],"Sarcoma, Synovial","Sarcoma,Soft Tissue","Melanoma Stage IV","Triple Negative Breast Cancer","Metastatic Cancer","Non Small Cell Lung Cancer","Bladder Urothelial Carcinoma","Ovary Cancer",[79,80,81,82],"NY-ESO-1","TCR","adoptive transfer","retroviral transduction","RECRUITING","2025-09-29",{"date":86,"type":47},"2025-10-02",{"date":88,"type":47},"2022-04-01",{"date":90,"type":22},"2027-12-30",{"name":92,"class":54},"Hadassah Medical Organization",1]