{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["24(1)"],"submitter":["Topp M"],"pubmed_abstract":["<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 ass"],"journal":["Trials"],"pagination":["4"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9808944"],"repository":["biostudies-literature"],"pubmed_title":["Safety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies."],"pmcid":["PMC9808944"],"pubmed_authors":["Alland L","Schwarz SE","Mayer J","Grosicki S","Strassz A","Skotnicki AB","Salogub G","Gural A","Hess G","Klein AK","Pietzko K","Topp M","Viardot A","Gartner U","Dlugosz-Danecka M","Michel CS"],"additional_accession":[]},"is_claimable":false,"name":"Safety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies.","description":"<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 ass","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jan","modification":"2026-05-28T06:18:51.002Z","creation":"2024-11-08T21:05:21.854Z"},"accession":"S-EPMC9808944","cross_references":{"pubmed":["36597128"],"doi":["10.1186/s13063-022-06982-7"]}}