Cancer – PEPN1812: A Phase 1 Trial of the CD123 X CD3 Dual Affinity Re-Targeting Antibody Flotetuzumab in Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia
Condition or Therapy:
Relapsed/Refractory Acute Myeloid Leukemia
Cancer and Blood Disorders
Study Number: PEPN1812
What is the goal of this study?
The overall goals of this study are to:
- Find the highest safe dose of flotetuzumab that can be given without causing severe side effects;
- Learn what kind of side effects flotetuzumab can cause;
- Learn more about the pharmacology (how your body handles the drug) of flotetuzumab;
- Learn more about the effects of flotetuzumab on your immune system;
- Determine whether flotetuzumab is a beneficial treatment for cancer
This is called a Phase 1 study because the goal is to find the highest dose of flotetuzumab that we can give safely.
Who can join the study?
This study may be a good fit for children and young adults who:
- Are at least 20 years old at time of enrollment
- Weigh at least 17 kg
Weight limit is due to constraints related to the concentration of the current drug formulation. If a new formulation of flotetuzumab becomes available to allow dosing of smaller patients, the protocol will be amended.
What will happen if my child takes part in this study?
You can read more about this study on clinicaltrial.gov.
Who can I contact for more information?
To learn more, call 206-987-2106 or email the study coordinator.