[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570609":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":25,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Instituto de Investigación Hospital Universitario La Paz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Children and young adults with CD19+\u002F- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.",[13],"Biological: Autologous CD19\u002FCD22 CAR T cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B","Children and youn adults with T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.",[18],"Biological: Allogeneic CART-NKG2D cells",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Autologous CD19\u002FCD22 CAR T cells","A total of two doses of autologous CD19\u002FCD22 CAR T cells (first dose of up to 0.75x106\u002Fkg fresh cells), and a second infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 cytokine-release syndrome (CRS) in the next 72 h; intravenously.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Allogeneic CART-NKG2D cells","A total of up to 3x106\u002Fkg allogeneic CART-NKG2D cells divided in three doses of up to 1x106\u002Fkg will be infused; intravenously. First infusion of fresh cells, and the 2nd and 3rd infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 CRS (every 48 hours).",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Antonio Pérez Martínez, MD","CONTACT","917 27 75 76","aperezmartinez@salud.madrid.org",[37],{"facility":38,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital Universitario La Paz","RECRUITING","Madrid","28046","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],-3.70256,40.4165,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100570609","phase-1-phase-i-clinical-trial-of-cart-cell-therapy-for-refractoryrelapsed-acute-lymphoblastic-leukemia-in-children-adolescents-and-young-adults-100570609",false,"NCT06709469","Phase I Clinical Trial of CART Cell Therapy for Refractory\u002FRelapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults","A Phase I Clinical Trial of CART Cell Therapy for Refractory\u002F Relapsed Acute Lymphoblastic Leukemia With Unmet Needs in Children, Adolescents and Young Adults: Feasibility and Safety Study (REALL_CART).","REALL_CART","Inclusion Criteria:\n\n* ARM A: CD19+\u002F- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Treatment with previous CART CD19 therapy is permitted, but is not mandatory, OR:\n* ARM B: T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.\n* Patients diagnosed with ALL must be suitable for allogeneic HSCT and willing to proceed to transplant if the CART treatment induces complete remission and the investigator believes it is the best option.\n* For ARM B there must be a suitable haploidentical donor (following local standard operating procedures).\n* Lansky (age \\\u003C16 years) or Karnofsky (age ≥16 years) score of 50 or greater.\n* Life expectancy greater than 12 weeks.\n* Absolute neutrophil count (ANC) ≥ 500\u002FμL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.\n* Platelet count ≥ 50,000\u002FμL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.\n* Absolute lymphocyte count ≥ 100\u002FμL.\n* Adequate renal, hepatic, pulmonary, and cardiac function.\n* Adequate venous access and absence of contraindications for lymphoapheresis\n* Patients with a seizure disorder may be enrolled if well controlled with anticonvulsants.\n* Patients or patients' legal representative, parent(s), or guardian able to provide written informed consent.\n\nExclusion Criteria:\n\n* Enrolled in another clinical trial in the previous 4 weeks.\n* Active infection requiring systemic medical therapy including clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, adenovirus, BK-virus, HHV-6 or Aspergillus.\n* Any of the following cardiac criteria: cardiac echocardiography with LVSF\\\u003C30% or LVEF\\\u003C40%; or clinically significant pericardial effusion.\n* Presence of CNS-3 disease or uncontrolled seizure disorder.\n* Active immunosuppressive therapy with the exception of prednisone 10 mg\u002Fday (or equivalent), within 7 days prior to enrolment.\n* GFR \\\u003C30 ml\u002Fmin or bilirubin \\>3 times the upper limit of normality (unless due to Gilbert's syndrome).\n* Any other condition that, in the opinion of the PI, may interfere with the efficacy and\u002For safety evaluation of the trial.\n* Pregnant or lactating women.\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests. Male partner should use a condom. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant.\n* Sexually active males should use a condom during intercourse for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests.","ALL","30 Years",{"count":65,"type":66},10,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed\u002Frefractory CD19+ B cell acute lymphoblastic leukemia (r\u002Fr B-ALL) or relapsed\u002Frefractory T-cell acute lymphoblastic leukemia (r\u002Fr T-ALL). The main questions it aims to answer are:\n\n1. The safety and feasibility of autologous CART-19\u002F22 in children, adolescents and young adults with a CD19+\u002F- CD22+ relapse\u002F refractory disease for a r\u002Fr B-ALL.\n2. The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r\u002Fr T-ALL.",[72],"Precursor Cell Lymphoblastic Leukemia-Lymphoma","2025-09-19",{"date":75,"type":76},"2025-09-22","ACTUAL",{"date":78,"type":76},"2025-07-08",{"date":80,"type":66},"2030-12-01",{"name":5,"class":6},1]