[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100243169":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":57,"studyPopulation":50,"armGroups":58,"interventions":69,"overallOfficials":93,"centralContacts":98,"locations":104,"responsibleParty":139,"collaborators":50,"id":141,"slug":50,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":50,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":50,"maxAge":148,"enrollmentInfo":149,"targetDuration":50,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":107,"whyStopped":50,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"University College, London","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":50},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of unacceptable toxicity following CD19+CD22 CAR T-cell infusion","The incidence of unacceptable toxicity occurring within 28 days of CD19+CD22CAR T-cell infusion.","28 days",{"measure":14,"description":15,"timeFrame":12},"Molecular remission","Efficacy will be assessed by determining Minimal Residual Disease in the bone marrow aspirate using immunoglobulin heavy chain (IgH) quantitative polymerase chain reaction (qPCR) and\u002For Next Generation Sequencing in all patients. The proportion of patients achieving molecular remission at 28 days post CD19+CD22CAR T-cell infusion will be determined.",[17,21,25,29,33,36,39,42,45,47],{"measure":18,"description":19,"timeFrame":20},"Feasibility of Generation of CD19+CD22 CAR T-cells","Evaluated by the number of therapeutic products generated.","Day 28",{"measure":22,"description":23,"timeFrame":24},"Molecular Remission","Efficacy will be assessed by determining Minimal Residual Disease in the bone marrow aspirate using immunoglobulin heavy chain (IgH) quantitative polymerase chain reaction (qPCR) and\u002For Next Generation Sequencing in all patients. The proportion of patients achieving molecular remission at 3 months post CD19+CD22CAR T-cell infusion will be determined.","3 months",{"measure":26,"description":27,"timeFrame":28},"Long-Term Molecular Remission","Number of patients in molecular remission without further therapy at 1 and 2 years","2 years",{"measure":30,"description":31,"timeFrame":32},"Duration of Response","Duration of response is measured from the time of achieving molecular remission or flow MRD negativity until the disease relapse or death, whichever occurs first.","15 years",{"measure":34,"description":35,"timeFrame":32},"Safety and Tolerability of the CAR T-cells","Incidence of adverse events and reactions (toxicity) to the CAR T-cells.",{"measure":37,"description":38,"timeFrame":28},"Incidence of B Aplasia","Incidence of B aplasia",{"measure":40,"description":41,"timeFrame":28},"Incidence of Hypogammaglobulinaemia","Incidence of hypogammaglobulinaemia",{"measure":43,"description":44,"timeFrame":28},"Frequency of Circulating CD19+CD22 CAR T-cells","Persistence and frequency of circulating CD19+CD22CAR T-cells in the peripheral blood by flow cytometry and qPCR analyses.",{"measure":46,"description":46,"timeFrame":28},"Relapse rate",{"measure":48,"description":49,"timeFrame":28},"Overall Survival (OS)","Overall Survival (OS) at 1 and 2 years",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"NA","SINGLE_GROUP","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE","This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19+CD22 Chimeric Antigen Receptor (CAR) T-cells (CD19+CD22 CAR T-cells) in children and young adults (age \\\u003C24 years) with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19+CD22 CAR T-cells. Patients will receive the CD19+CD22CAR T-cells following lymphodepleting chemotherapy and total body irradiation. The study will evaluate the safety, efficacy and duration of response of the CD19+CD22 CAR T-cells in children with high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia.",[59],{"label":60,"type":61,"description":62,"interventionNames":63},"CD19+CD22 CAR T-cells","EXPERIMENTAL","Patients meeting the eligibility criteria will have leukapheresis to isolate the blood immune cells used to manufacture the CD19+CD22CAR T-cells. Patients will receive lymphodepletion with low dose total body irradiation, fludarabine and cyclophosphamide prior to infusion of the CD19+CD22CAR T-cells.",[64,65,66,67,68],"Procedure: Leukapheresis","Radiation: Total Body Irradiation (TBI)","Drug: Lymphodepletion with Fludarabine","Drug: Lymphodepletion with Cyclophosphamide","Biological: CD19+CD22 CAR T-cells",[70,75,80,85,89],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":50},"PROCEDURE","Leukapheresis","Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells",[60],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":50},"RADIATION","Total Body Irradiation (TBI)","Participants will receive low-dose total body irradiation delivered as a single fraction on day -7 prior to CD19+CD22CAR T-cell infusion.",[60],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":50},"DRUG","Lymphodepletion with Fludarabine","Patients will receive lymphodepleting chemotherapy with iv fludarabine on days -6 to -3 prior to CD19+CD22CAR T-cell infusion.",[60],{"type":81,"name":86,"description":87,"armGroupLabels":88,"otherNames":50},"Lymphodepletion with Cyclophosphamide","Patients will receive lymphodepleting chemotherapy with iv cyclophosphamide on days -6 to -5 prior to CD19+CD22CAR T-cell infusion.",[60],{"type":90,"name":60,"description":91,"armGroupLabels":92,"otherNames":50},"BIOLOGICAL","1 dose of CD19+CD22 CAR T-cells given as an intravenous injection through a Hickman line or PICC line (peripherally inserted central catheter) on day 0.",[60],[94],{"name":95,"affiliation":96,"role":97},"Persis Amrolia","UCL Institute of Child Health","STUDY_CHAIR",[99],{"name":100,"role":101,"phone":102,"phoneExt":50,"email":103},"Aniqa Tasnim","CONTACT","0203 108 4753","ctc.carpall@ucl.ac.uk",[105,120,128],{"facility":106,"status":107,"city":108,"state":50,"zip":50,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Great Ormond Street Hospital","RECRUITING","London","United Kingdom","UK",{"type":112,"coordinates":113},"Point",[114,115],-0.12574,51.50853,{"lat":115,"lon":114},[118],{"name":119,"role":101,"phone":50,"phoneExt":50,"email":50},"Prof. Persis Amrolia",{"facility":121,"status":107,"city":108,"state":50,"zip":50,"country":109,"countryCode":110,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"University College Hospital",{"type":112,"coordinates":123},[114,115],{"lat":115,"lon":114},[126],{"name":127,"role":101,"phone":50,"phoneExt":50,"email":50},"Dr Rachael Hough",{"facility":129,"status":107,"city":130,"state":50,"zip":50,"country":109,"countryCode":110,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Manchester Royal Children's Hospital","Manchester",{"type":112,"coordinates":132},[133,134],-2.23743,53.48095,{"lat":134,"lon":133},[137],{"name":138,"role":101,"phone":50,"phoneExt":50,"email":50},"Dr Denise Bonney",{"type":140,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100243169",false,"NCT02443831","CARPALL: Immunotherapy With CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia","Immunotherapy With CD19+CD22 CAR Redirected T-cells for High Risk\u002FRelapsed Paediatric CD19+ and CD22+ Acute Lymphoblastic Leukaemia","Inclusion Criteria:\n\n1. Children and young adults (age 24 years or younger) with high risk\u002Frelapsed CD19+ and CD22+ acute lymphoblastic leukaemia with:\n\n   1. Resistant disease (\\>5% blasts) at end of ALLTogether-1 protocol or equivalent induction\n   2. ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD \\>10-4 at week 9 ALLTogether-1 Protocol or equivalent).\n   3. High risk infant ALL (age \\\u003C 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count \\> 300 x 10\\^9\u002FL or poor steroid early response (i.e. circulating blast count \\>1x10\\^9\u002FL following 7 day steroid pre-phase of induction as per national guidelines or equivalent)\n   4. Any patient with t(17,19) TCF3-HLF rearrangement\n   5. High risk 1st relapse (defined as very early (relapse within 18 months of diagnosis) and early relapses (any patient relapsing on therapy or within 6 months of completing treatment) and any relapse with high risk genetics, namely (KMT2A (MLL) rearrangements, low hypodiploidy\u002Fnear haploidy, t(17;19)(q22;p13)\u002FTCF3-HLF, iAMP21 and t(1;19)(q21;p13)\u002FTCF3- PBX1, t(9;22)(34.1 q11.2)\u002FBCR-ABL1\n   6. Any on therapy relapse in patients age 16-24\n   7. Any relapse of infant ALL\n   8. ALL post ≥ 2nd relapse\n   9. Any refractory relapse of ALL (defined as \\> 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy)\n   10. ALL with MRD \\>10-4 prior to planned stem cell transplant\n   11. Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant\n   12. Any relapse of ALL after stem cell transplant as long as planned time of CD19+CD22CAR T cell infusion is \\> 4 months post-transplant\n   13. Early (defined as \\\u003C 6 months post-infusion) loss of B cell aplasia or any CD19+CD22+ relapse following CD19CAR T cell therapy with Tisagenlecleucel\n\n   Note patients with isolated CNS relapse meeting one or more of the criteria above are eligible for the study\n2. Agreement to have a pregnancy test, use adequate contraception (if applicable)\n3. Written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria for registration:\n\n1. Active Hepatitis B, C or HIV infection\n2. Oxygen saturation ≤ 90% on air\n3. Bilirubin \\> 3 x upper limit of normal\n4. Creatinine \\> 3 x upper limit of normal\n5. Women who are pregnant or breastfeeding\n6. Stem Cell Transplant patients only: active significant (overall Grade ≥ II, Seattle criteria) acute GVHD or moderate\u002F severe chronic GVHD (NIH consensus criteria) requiring systemic steroids.\n7. Inability to tolerate leucapheresis\n8. Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10) score ≤ 50%\n9. Pre-existing significant neurological disorder (other than CNS involvement of underlying haematological malignancy)\n10. CD19 negative or CD22 negative disease\n\nExclusion criteria for CD19+CD22CAR T-cell infusion:\n\n1. Severe intercurrent infection at the time of scheduled CD19+CD22 CAR T-cell infusion\n2. Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19+CD22 CAR T-cell infusion\n3. Allogeneic transplant recipients with active significant acute GVHD overall grade ≥II or moderate\u002Fsevere chronic GVHD requiring systemic steroids at the time of scheduled CD19+CD22 CAR T-cell infusion. Note: Such patients will be excluded until the patient is GVHD free and off steroids","ALL","24 Years",{"count":150,"type":151},50,"ESTIMATED","INTERVENTIONAL",[154],"PHASE1","This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia",[157],"Acute Lymphoblastic Leukemia",[159],"high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia","2026-05-18",{"date":162,"type":163},"2026-05-22","ACTUAL",{"date":165,"type":163},"2016-04",{"date":167,"type":151},"2041-12-31",{"name":5,"class":6},3]