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A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1, Open-label, Dose-escalation Trial of CD33xCD3 Bispecific Antibody in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT05077423•Y-mAbs Therapeutics

View on ClinicalTrials.gov

Summary

Pediatric patients (\<21 years at study entry) with relapsed or refractory acute myeloid leukemia (AML) will be treated with CD33\*CD3 a bispecific antibody to investigate the safety and tolerability of the drug.

Detailed Description

This is an open label, first in human dose escalation trial in pediatric patients with relapsed or refractory acute myeloid leukemia to assess the safety and tolerability of increasing doses of CD33xCD3 BsAb administered subcutaneously. A modified Bayesian Optimal Interval Design (mBOIN) design will be applied. The trial will start with accelerated titration using single patient cohorts until one grade ≥2 AE not clearly associated to underlying disease, thereafter the trial will continue with mBOIN titration.

Eligibility

Age

2 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent from legal guardian(s), patient and/or child obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations
•Age ≥2 years, and ≤21 years, and a minimum body weight of ≥11 kg
•Histologically confirmed relapsed or refractory AML (except acute promyelocytic leukemia) with no therapeutic options that may provide clinical benefit. Disease burden ≥5.0% in the bone marrow meets definition for enrollment.
•Karnofsky performance status ≥50 for ≥16 years / Lansky performance status ≥50 for \<16 years
•White blood cells (WBC) ≤25 x 109/L (may receive hydroxyurea to bring WBC count down prior to first dose of CD33xCD3 BsAb and during Cycle 1 or low dose cytarabine up to 48 h prior to first dose of CD33xCD3 BsAb)
•Central Nervous System (CNS) disease as per Children's Oncology Group
•* Patients must have the status of CNS1 and no clinical signs or neurologic symptoms suggestive of CNS leukemia, such as cranial palsy
•* Patients with CNS3 or CNS2 status may receive antecedent intrathecal chemotherapy to achieve CNS1 status prior to trial entry
•* Patients with a history of CNS chloromatous disease are required to have no radiographic evidence of disease prior to enrollment
•Has acceptable liver and kidney laboratory values
+1 more criteria

Exclusion Criteria

•History of uncontrolled seizure. If on anti-convulsant and/or seizures are well controlled as per treating physician enrollment is acceptable
•Acute promyelocytic leukemia with PML-RARA genetic abnormality according to WHO classification or t(15;17)
•Isolated extramedullary AML
•Clinically significant graft-versus-host disease (GvHD) secondary to prior allogeneic transplantation. No immunosuppressive therapy for ≥14 days prior to first dose, except for topical corticosteroids for minor rash (\<5% of BSA) or adrenal replacement therapy
•Patient known to have one of the following genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Nijmegen breakage syndrome, Kostmann syndrome, Shwachman Diamond syndrome or any known bone marrow failure syndrome where increased risk for toxicity may be expected as judged by the Investigator
•Treatment with another investigational agent under the following conditions:
•* Within two weeks (four weeks for biologics) before first administration of CD33xCD3 BsAb; or
•* Patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the Investigator

Locations (13)

Children's of Alabama/University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's Hospital of Orange County

Orange, California, United States

UCSF Benioff Children's Hospital

San Francisco, California, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

May 25, 2022

Primary Completion Date

December 1, 2022

Completion Date

December 1, 2022

Last Updated

May 30, 2023

Enrollment

ACTUAL participants

Conditions

AML, Childhood

Interventions

CD33*CD3 BsAb

DRUG

Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML

NCT06158828

AML, ChildhoodAml+2 more

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RECRUITINGPHASE2

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

NCT06221683

AML, ChildhoodAcute Myeloid Leukemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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