Clinical Pharmacology of Tisagenlecleucel in B-cell Acute Lymphoblastic Leukemia.

ABSTRACT:

Purpose

Tisagenlecleucel is an anti-CD19 chimeric antigen receptor (CAR19) T-cell therapy approved for the treatment of children and young adults with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).

Patients and methods

We evaluated the cellular kinetics of tisagenlecleucel, the effect of patient factors, humoral immunogenicity, and manufacturing attributes on its kinetics, and exposure-response analysis for efficacy, safety and pharmacodynamic endpoints in 79 patients across two studies in pediatric B-ALL (ELIANA and ENSIGN).

Results

Using quantitative polymerase chain reaction to quantify levels of tisagenlecleucel transgene, responders (N = 62) had ≈2-fold higher tisagenlecleucel expansion in peripheral blood than nonresponders (N</

SUBMITTER: Mueller KT 

PROVIDER: S-EPMC7433345 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature