{"entity":{"id":"nct06101381","kind":"trial","name":"CD19-directed CAR-T cell therapy for refractory or relapsed acute lymphoblastic leukaemia or non-Hodgkin lymphoma (CARTHEDRALL)","aka":["CARTHEDRALL","HEMO-02-CART"],"tldr":"A multicentre trial of a CAR-T cell therapy made at a Brazilian public university, for leukaemia and lymphoma that has come back or stopped responding.","summary":"CARTHEDRALL is a prospective, single-arm, multicentre phase 1/2 trial of an autologous anti-CD19 CAR-T cell produced at the University of São Paulo's Ribeirão Preto campus, given as a single infusion with five years of follow-up. ClinicalTrials.gov records it as started on 21 March 2024, recruiting, with an estimated 81 participants and primary completion estimated for December 2028. The lead sponsor is the University of São Paulo with the Blood Center of Ribeirão Preto and the Hospital das Clínicas de Ribeirão Preto as collaborators; sites are the Ribeirão Preto Medical School, the Hospital das Clínicas de São Paulo, the UNICAMP hospital in Campinas, Hospital Sírio-Libanês and A Beneficência Portuguesa de São Paulo. The principal investigator is Diego Villa Clé.\n\nIt follows 20 patients treated with the same academic product between 2019 and 2023 outside a trial, and is the route by which the Hemocentro aims to register a national CAR-T that the SUS can pay for.","status":"recruiting","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov: NCT06101381","url":"https://clinicaltrials.gov/study/NCT06101381"},{"label":"Hemocentro de Ribeirão Preto: Nutera RP, advanced therapy against cancer","url":"https://www.hemocentro.fmrp.usp.br/nutera-rp-terapia-avancada-no-combate-ao-cancer/"}],"tags":[],"related":[],"cancers":["all-leukemia","dlbcl"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":[],"companies":[],"institutions":["hemocentro-ribeirao-preto","sirio-libanes","bp-beneficencia-portuguesa"],"pathways":[],"terms":[],"trials":[],"people":["diego-villa-cle","rodrigo-calado"],"bottlenecks":[],"keyPapers":["paper-donadel-academic-cart19-brazil-bmt-2024"],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo country deep dive, Brazil (wave 2)","editedOn":"2026-11-03"},"nct":"NCT06101381","phase":"1/2","setting":"Relapsed or refractory CD19-positive B-cell acute lymphoblastic leukaemia or B-cell non-Hodgkin lymphoma","sponsor":"University of Sao Paulo","started":"2024-03-21","startedType":"actual","enrolled":81,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06101381/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"institution":[{"id":"bp-beneficencia-portuguesa","kind":"institution","name":"BP - A Beneficência Portuguesa de São Paulo","route":"/institutions/bp-beneficencia-portuguesa/"},{"id":"hemocentro-ribeirao-preto","kind":"institution","name":"Fundação Hemocentro de Ribeirão Preto","route":"/institutions/hemocentro-ribeirao-preto/"},{"id":"sirio-libanes","kind":"institution","name":"Hospital Sírio-Libanês","route":"/institutions/sirio-libanes/"}],"person":[{"id":"diego-villa-cle","kind":"person","name":"Diego Villa Clé","route":"/people/diego-villa-cle/"},{"id":"rodrigo-calado","kind":"person","name":"Rodrigo Calado","route":"/people/rodrigo-calado/"}],"paper":[{"id":"paper-donadel-academic-cart19-brazil-bmt-2024","kind":"paper","name":"Safety and efficacy of a new academic CD19-directed CAR-T cell for refractory/relapsed non-Hodgkin lymphoma and acute lymphoblastic leukemia in Brazil","route":"/key-papers/paper-donadel-academic-cart19-brazil-bmt-2024/"}]}}