Perseus Proteomics Inc. announced that PMDA has finished investigation of the clinical trial notification of the Phase I/II investigator-led clinical trial. The clinical trial will be performed among aggressive NK-cell leukemia (ANKL) patients using the in-development anti-transferrin receptor antibody PPMX-T003 as a therapeutic drug and will start after the review and approval by IRB at respective clinical trial institution and registration of participating patients. ANKL is a blood cancer categorized as malignant lymphoma, and originates in NK (natural killer) cells,one of immune cells.

It is fulminant type of refractory hematological malignancy, where symptoms will progress rapidly once developed. Due to the rarity of the disease with few reported cases, there is a need to discover its causes and establish the effective standard treatment as soon as possible. Under such Circumstances, the research and development on PPMX-T003 as a new therapeutic drug of ANKL was adopted as Project Promoting Support for Drug Discovery Support Program for Orphan drug prior to the Designation by AMED in March 2022.

Following the adoption, this investigator-led clinical trial will be conducted for the purpose of assessing the safety and tolerability in administering PPMX-T003 to NKL patients, as well as efficacy and pharmacokinetics.