CD3-binding (T cell engaging) immune stimulating antibody-based therapies


We are delighted that you have chosen the Therapeutic Modalities module to start or enhance your current educational journey in immuno-safety science. This lecture is one in a series of five providing detailed information on current and/or emerging therapeutics that interact with the immune system and is led by Dr. Benno Rattel at AMGEN. Please review the learning objectives below for more information on what you will learn in this lecture.
If you are new to HESI and would like to learn more about our organization, please take a moment to visit our website at

Target Audience

This course is intended for the science professional or graduate student looking to learn the fundamental science and key consideration that are examined in immune safety assessment. Advanced topics and coursed that take a deeper dive into specific scientific areas will be offered and are recommended for the more experienced scientist who has a firm grasp of the information highlighted in the introduction module.

Learning Objectives

The learner will:
  • Understand the pharmacology of T cell engaging molecules and the spectrum of safety liabilities resulting from their mode of action.
  • Specific challenges for in vivo nonclinical safety studies performed with TCEs i.e. sampling schedules, cytokine release, ADAs, on-target off-tumor toxicity.
  • Typical nonclinical pharmacology and toxicology package required to support FIH studies and BLA submission.
  • Current hot topics in the development of TCEs i.e. requirement for 3-month studies, studies required for well-characterized targets, use of surrogate molecules, transgenic animal models.
Course summary
Available credit: 
  • 1.00 Participation
Course opens: 
Course expires: 

Lectures in this module

CAR Therapy
Safety Considerations for Oligonucleotides
CD3-binding (T cell engaging) immune stimulating antibody-based therapies
Gene Therapy
Nonclinical Development of Biologics
Benno Rattel, DVM PhD

Available Credit

  • 1.00 Participation


Please login or register to take this course.

Required Hardware/software

This platform, Ethos CE, works with most modern web browsers (e.g., Chrome, Internet Explorer, MS Edge, Safari). Contact if you are having any difficulties with this platform.