Selection of isatuximab dosing regimen in pediatric patients with leukemia using population pharmacokinetics.

ABSTRACT:

Purpose

Isatuximab, an immunoglobulin G monoclonal antibody that targets a specific CD38 epitope, is approved in combination with dexamethasone plus either pomalidomide or carfilzomib for treatment of adults with relapsed or refractory (R/R) multiple myeloma. Isatuximab demonstrated significant anti-leukemic activity in preclinical models. In the phase 2 ISAKIDS study (NCT03860844), isatuximab was tested as combination therapy for pediatric patients with R/R acute lymphoblastic leukemia and acute myeloid leukemia. Here, we use population pharmacokinetics (PopPK) to select the appropriate isatuximab dose for infants aged 1-24 months in ISAKIDS.

Methods

An initial PK modeling and simulation strategy was applied to the first 18 tested patients to confirm the isatuximab 20-mg/kg

SUBMITTER: Brillac C 

PROVIDER: S-EPMC12672809 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature