Regulatory Measures to Improve the Safety of CAR-T-Cell Treatment.

ABSTRACT:

Introduction

Regulatory activities aim to facilitate the safe use of novel therapeutics such as genetically engineered chimeric antigen receptor (CAR)-T cells. Toxicities associated with CAR-T-cell therapies have led to modified safety management guidance in clinical trials and the implementation of post-marketing requirements. The aim of this study was to estimate the effect of individual risk-minimizing measures to evaluate the appropriateness of regulatory activities.

Methods

We re-examined clinical trial data prior to and after the introduction of revised treatment guidelines; we analysed spontaneous adverse drug reaction (ADR) reports submitted to the EudraVigilance database in 2019/2020 regarding their completeness; and we performed a survey of treatment centres in Ger

SUBMITTER: Berg P 

PROVIDER: S-EPMC10331154 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature