{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Woyach JA"],"funding":["NCI NIH HHS"],"pagination":["3553-60"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC4256907"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["124(24)"],"pubmed_abstract":["CD19 is ubiquitously expressed on chronic lymphocytic leukemia (CLL) cells and is therefore an attractive candidate for antibody targeting. XmAb5574 (aka MOR00208) is a novel humanized CD19 monoclonal antibody with an engineered Fc region to enhance Fcγ receptor binding affinity. Here we report results of a first in human phase 1 trial of XmAb5574 in patients with relapsed or refractory CLL. Twenty-seven patients were enrolled to 6 escalating dose levels, with expansion at the highest dose level of 12 mg/kg. Nine doses of XmAb5574 were infused over 8 weeks. No maximal tolerated dose was reached, and the drug was generally well tolerated, with infusion reactions of grades 1 and 2 being the most common toxicities. Grade 3 and 4 toxicities occurred in 5 patients and included neutropenia, thro"],"journal":["Blood"],"pubmed_title":["A phase 1 trial of the Fc-engineered CD19 antibody XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL."],"pmcid":["PMC4256907"],"funding_grant_id":["P01 CA095426","K23 CA178183","P01 CA95426","5 P50-CA140158","P50 CA140158"],"pubmed_authors":["Foster PA","Huang Y","Lozanski G","Berdeja JG","Byrd JC","Flinn IW","Awan F","Woyach JA","Mansoor S","Wiley E"],"additional_accession":[]},"is_claimable":false,"name":"A phase 1 trial of the Fc-engineered CD19 antibody XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL.","description":"CD19 is ubiquitously expressed on chronic lymphocytic leukemia (CLL) cells and is therefore an attractive candidate for antibody targeting. XmAb5574 (aka MOR00208) is a novel humanized CD19 monoclonal antibody with an engineered Fc region to enhance Fcγ receptor binding affinity. Here we report results of a first in human phase 1 trial of XmAb5574 in patients with relapsed or refractory CLL. Twenty-seven patients were enrolled to 6 escalating dose levels, with expansion at the highest dose level of 12 mg/kg. Nine doses of XmAb5574 were infused over 8 weeks. No maximal tolerated dose was reached, and the drug was generally well tolerated, with infusion reactions of grades 1 and 2 being the most common toxicities. Grade 3 and 4 toxicities occurred in 5 patients and included neutropenia, thro","dates":{"release":"2014-01-01T00:00:00Z","publication":"2014 Dec","modification":"2025-04-20T00:31:42.884Z","creation":"2019-03-27T01:41:07Z"},"accession":"S-EPMC4256907","cross_references":{"pubmed":["25301708"],"doi":["10.1182/blood-2014-08-593269"]}}