[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635751":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":62,"collaborators":19,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":19,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":19,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"ImmunityBio, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19 t-haNK Arm","EXPERIMENTAL","IV infusion of CD19 t-haNK",[13],"Drug: CD19 t-haNK",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","CD19 t-haNK",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Kayleigh Russell","CONTACT","424-539-2412","kayleigh.russell@immunitybio.com",{"name":27,"role":23,"phone":19,"phoneExt":19,"email":28},"Mark Nelson","mark.nelson@immunitybio.com",[30,48],{"facility":31,"status":32,"city":33,"state":19,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Dr Jackie Thomson Inc","RECRUITING","Johannesburg","2193","South Africa","ZA",{"type":38,"coordinates":39},"Point",[40,41],28.04363,-26.20227,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":46,"phoneExt":19,"email":47},"Jackie Thompson","+27 011 053 1200","Jackie@bonemarrowtransplant.co.za",{"facility":49,"status":32,"city":50,"state":19,"zip":51,"country":35,"countryCode":36,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Alberts Cellular Therapy","Pretoria","0044",{"type":38,"coordinates":53},[54,55],28.18783,-25.74486,{"lat":55,"lon":54},[58],{"name":59,"role":23,"phone":60,"phoneExt":19,"email":61},"David Brittain","+27 012 993 2555","david@abj.org.za",{"type":63,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100635751","phase-1-a-safety-and-efficacy-study-of-cd-19-t-hank-in-patients-with-b-cell-acute-lymphoblastic-leukemia-100635751",false,"NCT07556757","A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia","A Phase 1 Open-label Study of CD19 t-hANK as a Single Agent in Participants With Selected CD19+ Relapsed B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age ≥ 12 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.\n3. Histologically or flow cytometry documented pre B-ALL.\n4. Relapsed after achieving a 2nd complete remission (CR) or failed one cycle of re-induction therapy or with MRD positivity after ≥ 2 cycles of induction.\n5. Must be willing to undergo a lumbar puncture (LP) for CSF analysis and administration of IT chemotherapy.\n6. Performance status: Lansky score \\>60%, for participant ≥12 to \\\u003C16 years. Eastern Cooperative Oncology Group (ECOG) score of ≤ 1 for participants ≥ 16 years.\n7. Expected survival \\> 16 weeks.\n8. Stated willingness to comply with study procedures.\n9. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n10. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), and implants such as intrauterine devices (IUDs).\n\nAll inclusion criteria must be answered \"yes\" for a participant to participate in the trial.\n\nExclusion Criteria:\n\n1. Participants with T-cell leukaemia and Burkitt's M3 leukaemia.\n2. Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).\n3. Inadequate organ function, evidenced by the following laboratory results:\n\n   1. Serum creatinine ≥ 2 mg\u002FdL\n   2. Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) ≥ 5 upper limit of normal (ULN)\n   3. Total bilirubin ≥ 2 mg\u002FdL\n4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment related complications.\n5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n7. History of receiving allograft organ transplant requiring immunosuppression.\n8. Participants post solid organ transplant who develop high grade lymphomas or leukaemias.\n9. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).\n10. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n11. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.\n12. Current chronic daily treatment (continuous for \\> 3 months) with systemic corticosteroids defined as \\> 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n13. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n14. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and a detectable HIV viral load.\n15. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n16. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n18. Women who are pregnant or breastfeeding.\n\nAll exclusion criteria must be answered \"no\" for a participant to participate in the trial.","ALL","12 Years",{"count":74,"type":75},10,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","This is a phase 1, open-label study to evaluate the safety and efficacy of CD19 t-haNK in patients with B-cell acute lymphoblastic leukemia. Up to 10 patients will receive at least 1 dose of study drug.",[81,82],"B-ALL","Leukemia",[84,85,86],"B-Cell","Acute","Lymphoblastic","2026-04-22",{"date":89,"type":90},"2026-04-29","ACTUAL",{"date":92,"type":90},"2025-04-11",{"date":94,"type":75},"2028-12",{"name":5,"class":6},2]