biostudies-literatureBenjamin RNCI NIH HHSe833-e843https://www.ebi.ac.uk/biostudies/studies/S-EPMC11575699biostudies-literatureUnknown9(11)<h4>Background</h4>The prognosis for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia remains poor. UCART19, an allogeneic genome-edited anti-CD19 chimeric antigen receptor (CAR) T-cell product derived from healthy donors and available for immediate clinical use, offers a potential therapeutic option for such patients. The CALM trial is a first-in-human study evaluating the safety and antileukaemic activity of UCART19 in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia.<h4>Methods</h4>This phase 1, open-label study was conducted at eight centres across France, the UK, the USA, and Japan. Adult patients aged 16-70 years with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukaemia who had morphological relapse or a minimThe Lancet. HaematologyUCART19, a first-in-class allogeneic anti-CD19 chimeric antigen receptor T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (CALM): a phase 1, dose-escalation trial.PMC11575699P30 CA016672Mediavilla CMeunier MBoucaud FPagliuca ATremorin MTMaus MMadelaine IHock HMetaxa VDunlop AStewart OMcKeown MAYallop DGianella-Borradori ALewis JJain NGraham CBonnin AChu VDevereux SSanderson RJabbour EMason AKonopleva MMathews RPotter VVekhoff ABonganay LItzykson RFouliard SClappier EDulery RMarchiq IDupouy SRice CBinlich FMufti GMohty MKassam SGiemza EAlmena-Carrasco MCaillat-Zucman SCelli-Lebras KFrigault MJKebriaei PFrigault MCatt LJones EEllard RSpitzer TFarzeneh FLarghero JMalard FFolarin NWierda WRaffoux EKato KCuthill KMcGee KMaus MVLengline EBenjamin RBalandraud SCasey KAzoulay ETeshima TChappell JCheung GMunro HToncheva VRabian FPannaux MBoissel NCALM Study GroupKazmi MLiskova MKantarjian HDaguenel-Nguyen APatten PBrown JSaleem AKuhnl ALedraa TJozwik ABrissot EfalseUCART19, a first-in-class allogeneic anti-CD19 chimeric antigen receptor T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (CALM): a phase 1, dose-escalation trial.<h4>Background</h4>The prognosis for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia remains poor. UCART19, an allogeneic genome-edited anti-CD19 chimeric antigen receptor (CAR) T-cell product derived from healthy donors and available for immediate clinical use, offers a potential therapeutic option for such patients. The CALM trial is a first-in-human study evaluating the safety and antileukaemic activity of UCART19 in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia.<h4>Methods</h4>This phase 1, open-label study was conducted at eight centres across France, the UK, the USA, and Japan. Adult patients aged 16-70 years with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukaemia who had morphological relapse or a minim2022-01-01T00:00:00Z2022 Nov2026-06-02T16:11:57.189Z2025-04-04T11:42:29.407ZS-EPMC115756993622864310.1016/s2352-3026(22)00245-910.1016/S2352-3026(22)00245-9