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ADVL2111: Phase 1 Trial of CD33xCD3 Bispecific Antibody Therapy in Children with Relapsed or Refractory Acute Myeloid Leukemia

About this study

This research study will test a new medicine called a bispecific antibody in children with acute myeloid leukemia (AML) that has come back (relapsed) or never went away despite chemotherapy (refractory). The name of the bispecific antibody is CD33xCD3. An antibody is a protein used by the immune system to find and destroy foreign molecules.

A bispecific antibody tries to bring parts of the immune system called T cells together with AML cells to help the T cells kill the leukemia cells. The antibody in this study targets a protein called CD33. This protein is found on most AML cells.

Scientists want to find the best dose of the antibody that can be safely given to children with relapsed or refractory AML. The researchers also want to learn more about how this antibody targets AML.

Eligibility overview

  • Have relapsed or refractory AML
  • Ages 2 to 21 years
  • Weigh more than 24 lbs.

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

A Phase 1, Open-label, Dose-escalation trial of CD33xCD3 Bispecific Antibody in Pediatric patients with Relapsed or Refractory Acute Myeloid Leukemia

Study goal:

The goal of this study is to find out: 1) how CD33xCD3 bispecific antibody works in a child’s body; 2) the best dose of this antibody, and 3) how AML responds to the antibody.


Ages 2 to 21 years

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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