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ADVL2111: Bispecific Antibody Therapy for Acute Myeloid Leukemia (AML)

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


Leukemia / Lymphoma

Diseases Treated:

Acute myeloid leukemia (AML)

Eligibility Overview:

  • Relapsed or refractory AML
  • Ages 2 to 21 years
  1. Brief Summary

    Survival rates for children with relapsed AML are poor due to chemotherapy resistance in AML blasts and stem cells. Activating the immune system to attack AML may provide an alternative method of achieving remission. This research study evaluates a CD33xCD3 bispecific antibody in children with relapsed or refractory AML. The primary outcome is the maximum tolerated and recommended phase 2 dose of this agent.

    Primary Objectives: 

    • Determine the maximum tolerated dose, the optimal biological dose and the recommended phase 2 dose of CD33xCD3 BsAb
    • Assess the safety and tolerability of different doses of CD33xCD3 BsAb

    Secondary Objectives: 

    • Assess the pharmacokinetics of different doses of CD33xCD3 BsAb
    • Assess its immunogenicity  
    • Describe its antileukemic activity

    Eligibility Criteria

    Inclusion criteria include:

    • Relapsed or refractory AML (except acute promyelocytic leukemia) with no therapeutic options that may provide clinical benefit
    • Ages 2 to 21 years, with minimum body weight of 11 kg
    • Recovered from any acute toxic effects of prior anti-cancer therapies
    • Acceptable liver and kidney function
    • No clinical signs or neurologic symptoms suggesting CNS leukemia

    Exclusion criteria include:

    • History of uncontrolled seizure
    • Acute promyelocytic leukemia with PML-RARA genetic abnormality
    • Isolated extramedullary AML
    • Clinically significant graft-versus-host disease (GvHD) secondary to prior allogeneic transplantation
    • Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Nijmegen breakage syndrome, Kostmann syndrome, Shwachman Diamond syndrome or any known bone marrow failure syndrome with increased risk for toxicity

    Study Sites

    St. Jude Children’s Research Hospital and other locations in the U.S.

  2. 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 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.

    Purpose of This Clinical Trial

    The goal of this study is to find out:

    • How CD33xCD3 bispecific antibody works in a child’s body
    • The best dose of this antibody
    • How AML responds to the antibody

    Eligibility Overview

    • Have relapsed or refractory AML
    • Ages 2 to 21 years
    • Weigh more than 24 lbs.
  3. ADVL2111  Quick View
    Y-mAbs Therapeutics Inc., Children’s Oncology Group identifier NCT05077423
    Trial start date May 2022
    Estimated enrollment 36
    Study type Interventional
    Study phase Phase I

    Acute myeloid leukemia (AML)

    Ages 2 years to 21 years
    Principal investigator Seth Karol, MD
    Study site St. Jude Children’s Research Hospital
    For a consultation or to discuss ADVL2111 St. Jude Physician/Patient Referral Office


Seth Karol, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

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.