[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575876":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":60,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":23,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":23,"maxAge":70,"enrollmentInfo":71,"targetDuration":23,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":23,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19-CD22-CAR T cell therapy","EXPERIMENTAL","This study has two parts:\n\nCollection and Manufacturing Phase - Patients will have white blood cells collected in the St. Jude Blood Donor Center through a procedure called apheresis, or your doctors may use a previously collected frozen product. The collected cells will be engineered to improve their ability to recognize and kill cancer cells. The final cell product is referred to as the CD19-CD22 CAR T cells.\n\nTreatment Phase - Eligible patients will receive chemotherapy before receiving the CAR T cells.",[13,14,15,16],"Drug: Fludarabine","Drug: Cyclophosphamide","Drug: Mesna","Device: CD19-CD22 CAR T cell infusion",[18,24,27,30],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Fludarabine","IV",[9],null,{"type":19,"name":25,"description":21,"armGroupLabels":26,"otherNames":23},"Cyclophosphamide",[9],{"type":19,"name":28,"description":21,"armGroupLabels":29,"otherNames":23},"Mesna",[9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":23},"DEVICE","CD19-CD22 CAR T cell infusion","CAR T cell infusion will be given intravenously, either centrally or peripherally.",[9],[36],{"name":37,"affiliation":5,"role":38},"Rebecca Epperly, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":23,"email":43},"CONTACT","888-226-4343","referralinfo@stjude.org",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-90.04898,35.14953,{"lat":56,"lon":55},[59],{"name":37,"role":41,"phone":42,"phoneExt":23,"email":43},{"type":61,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100575876","phase-1-cd19-cd22-bispecific-chimeric-antigen-receptor-car-t-cell-therapy-for-pediatric-patients-with-acute-lymphoblastic-leukemia-100575876",false,"NCT06777979","CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia","CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)","Collection and Manufacturing Eligibility\n\nInclusion Criteria:\n\n* Age \\\u003C21 years old\n* Relapsed\u002Frefractory CD19- and\u002For CD22-positive acute leukemia defined as:\n\n  \\*CD19 and\u002For CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy\n  * Second or greater relapse\n  * Any relapse after allogeneic HCT\n  * Refractory disease (primary or in relapse) despite therapy designed to induce remission\n* Estimated life expectancy of \\> 12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)\n* For females of childbearing age:\n\n  * Not lactating with intent to breastfeed\n  * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Known contraindication to receiving protocol defined lymphodepleting\n* chemotherapy regimen\n* History of hypersensitivity reaction to murine protein-containing products\n\nTreatment Eligibility\n\nInclusion Criteria:\n\n* Age \\\u003C 21 years old\n* Detectable disease in the bone marrow\n* Estimated life expectancy of \\> 8 weeks\n* Karnofsky or Lansky (age-dependent) performance score \\> 50 (Appendix A)\n* Adequate cardiac function defined as left ventricular ejection fraction \\>40%, or shortening fraction \\> 25%\n* EKG without evidence of clinically significant arrhythmia\n* Adequate renal function defined as creatinine clearance or radioisotope GFR \\>50 mL\u002Fmin\u002F1.73m2 (GFR \\>40 mL\u002Fmin\u002F1.73m2 if \\\u003C2 years of age)\n* Adequate pulmonary function defined as forced vital capacity (FVC) \\>50% of predicted value; or pulse oximetry \\>92% on room air\n* Total bilirubin \\\u003C 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 5 times the upper limit of normal for age\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion\n* For females of childbearing age:\n\n  * Not lactating with intent to breastfeed\n  * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment\n  * If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Known contraindication to receiving protocol defined lymphodepleting\n* chemotherapy regimen\n* History of hypersensitivity reactions to murine protein-containing products\n* Severe, uncontrolled bacterial, viral or fungal infection\n* Active CNS-3 disease\n* Evidence of active, uncontrolled neurologic disease","ALL","21 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells.\n\nPrimary Objective:\n\nTo determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent\u002Frefractory CD19- and\u002For CD22-positive leukemia.\n\nSecondary Objective:\n\nTo evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.",[79,80,81],"Acute Lymphoblastic Leukemia","Recurrent Acute Lymphoblastic Leukemia","Recurrent B Acute Lymphoblastic Leukemia","2026-05-18",{"date":84,"type":85},"2026-05-19","ACTUAL",{"date":87,"type":85},"2025-04-28",{"date":89,"type":73},"2031-01",{"name":5,"class":6},1]