A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
Stopped early · Phase 1
Conditions studied: AML, Childhood
In brief
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.
Key facts
- Study ID
- NCT05077423
- Run by
- Y-mAbs Therapeutics
- People needed
- 3
- Starts
- 2022-05-25
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2023-05-30
Who can join
Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Patient must have recovered from acute toxic effects of prior anti-cancer therapies prior to first dose of CD33xCD3 BsAb
You may not qualify if…
- 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
Where it is running
- 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
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
- St Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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