[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632820":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":29,"locations":39,"responsibleParty":75,"collaborators":79,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":117,"overallStatus":122,"whyStopped":11,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"St. Justine's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL",null,[13],"Drug: Therapeutic Inducers of Natural Killer Killing (ThINKK)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Therapeutic Inducers of Natural Killer Killing (ThINKK)","This study uses an adaptation of the classical 3+3 dose-escalation model. The Maximum Tolerated Dose (MTD) is determined as the highest dose level at which six patients are treated with no unacceptable increase in acute GvHD risk and with no more than one patient experiencing a DLT. The first cohort (3 patients) will receive 7.5 M ThINKK\u002Fm2 weekly for 4 weeks. Dose distribution for the escalation levels will be guided by the pharmacodynamic data from the initial cohort.. If the preliminary data show that TRAIL expression remains stable at Day +8, dose level 2 will be set at 15 × 10\\^6 \u002F m2 BSA weekly, and dose level 3 at 30 × 10\\^6 \u002F m2 BSA weekly. If the data instead indicate the need to shorten the dosing interval to maintain TRAIL expression, dose level 2 will be set at 7.5 × 10\\^6 \u002F m2 BSA bi-weekly and dose level 3 at 15 × 10\\^6 \u002F m2 BSA bi-weekly.",[9],[21],"ThINKK",[23,26],{"name":24,"affiliation":5,"role":25},"Michel Duval, MD","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":28},"Sabine Herblot, PhD","STUDY_DIRECTOR",[30,35],{"name":24,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","5143454931","6746","michel.duval@umontreal.ca",{"name":36,"role":31,"phone":32,"phoneExt":37,"email":38},"Karine Leveille","5324","karine.leveille.hsj@ssss.gouv.qc.ca",[40,59],{"facility":41,"status":11,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The Hospital for Sick Children","Toronto","Ontario","M5G1E8","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-79.39864,43.70643,{"lat":51,"lon":50},[54,58],{"name":55,"role":31,"phone":56,"phoneExt":11,"email":57},"Joerg Krueger, MD","4168131500","joerg.krueger@sickkids.ca",{"name":55,"role":25,"phone":11,"phoneExt":11,"email":11},{"facility":60,"status":11,"city":61,"state":62,"zip":63,"country":45,"countryCode":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"CHU Sainte-Justine","Montreal","Quebec","H3T1C5",{"type":48,"coordinates":65},[66,67],-73.58781,45.50884,{"lat":67,"lon":66},[70,74],{"name":71,"role":31,"phone":32,"phoneExt":72,"email":73},"Henrique Bittencourt, MD","2724","henrique.bittencourt.med@ssss.gouv.qc.ca",{"name":71,"role":25,"phone":11,"phoneExt":11,"email":11},{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Michel Duval","MD, Pediatric Hemato-Oncologist, Cell Therapy Lab Director",[80,82,85],{"name":81,"class":6},"Héma-Québec",{"name":83,"class":84},"ExCellThera inc.","INDUSTRY",{"name":86,"class":87},"Centre C3i","UNKNOWN","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":100,"type":101},12,"ESTIMATED","INTERVENTIONAL",[104],"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.",[107,108,109,110,111,112,113,114,115,116],"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",[118,119,120,121],"Thinkk","NK cells","pdc","immunotherapy","NOT_YET_RECRUITING","2026-04-02",{"date":125,"type":126},"2026-04-08","ACTUAL",{"date":128,"type":101},"2026-05-01",{"date":130,"type":101},"2029-05-01",{"name":77,"class":6},2]