biostudies-literatureUnknown24(1)Topp M<h4>Background</h4>The prognosis for patients with relapsed and/or refractory (R/R) non-Hodgkin's lymphoma (NHL) or acute lymphoblastic leukaemia (ALL) remains poor, with existing treatments having significant side effects. Developed for the treatment of these cancers, AFM11 is a tetravalent, bispecific humanised recombinant antibody construct (TandAb®) designed to bind to human CD19 and CD3 and lead to the activation of T cells inducing apoptosis and killing of malignant B cells.<h4>Methods</h4>Two open-label, multicentre, dose-escalation phase 1 studies evaluated the safety, pharmacokinetics and activity of AFM11 in patients with R/R CD19-positive B cell NHL (AFM11-101) and in patients with CD19 + B-precursor Philadelphia-chromosome negative ALL (AFM11-102). Adverse events (AEs) were assTrials4https://www.ebi.ac.uk/biostudies/studies/S-EPMC9808944biostudies-literatureSafety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies.PMC9808944Alland LSchwarz SEMayer JGrosicki SStrassz ASkotnicki ABSalogub GGural AHess GKlein AKPietzko KTopp MViardot AGartner UDlugosz-Danecka MMichel CSfalseSafety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies.<h4>Background</h4>The prognosis for patients with relapsed and/or refractory (R/R) non-Hodgkin's lymphoma (NHL) or acute lymphoblastic leukaemia (ALL) remains poor, with existing treatments having significant side effects. Developed for the treatment of these cancers, AFM11 is a tetravalent, bispecific humanised recombinant antibody construct (TandAb®) designed to bind to human CD19 and CD3 and lead to the activation of T cells inducing apoptosis and killing of malignant B cells.<h4>Methods</h4>Two open-label, multicentre, dose-escalation phase 1 studies evaluated the safety, pharmacokinetics and activity of AFM11 in patients with R/R CD19-positive B cell NHL (AFM11-101) and in patients with CD19 + B-precursor Philadelphia-chromosome negative ALL (AFM11-102). Adverse events (AEs) were ass2023-01-01T00:00:00Z2023 Jan2026-05-28T06:18:51.002Z2024-11-08T21:05:21.854ZS-EPMC98089443659712810.1186/s13063-022-06982-7