US Study of ECT-001-CB in Children and Young Adults with High-Risk Blood Cancers

Sponsor: ExCellThera inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04990323

Provider View

This clinical trial is testing a new cord blood transplant method using ECT-001-CB to help children and young adults with high-risk blood cancers who don't have a matching donor. The study aims to improve recovery and reduce complications after transplant.

Patient Parameters

Program Overview

Cord blood transplants are an option for patients who don't have a matching donor, but they often come with challenges like low cell counts and longer recovery times. This study is testing a new method using a molecule called UM171 to expand cord blood cells, which may help overcome these challenges. Previous studies in adults have shown promising results, with faster recovery and fewer complications. This new study will test the same approach in children and young adults with high-risk blood cancers. Initially, 12 patients will participate, and if the results are promising, the study will expand to include more patients.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with certain high-risk blood cancers, such as:
    • Acute Myeloid Leukemia (AML) with specific conditions like relapse or poor response to treatment.
    • Myelodysplastic Syndrome (MDS) with certain conditions like relapse or poor genetic markers.
    • Chronic Myelogenous Leukemia (CML) in blast crisis.
    • Mixed Phenotype Acute Leukemia with specific conditions.
    • Juvenile Myelo-Monocytic Leukemia (JMML).
  • Availability of two cord blood units with specific matching and cell count requirements.
  • General health requirements, including:
    • Performance status score above 60%.
    • Normal liver and kidney function.
    • Adequate heart and lung function.
  • Signed informed consent.
  • Female patients of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.

Exclusion Criteria

  • Previous cord blood transplant within the last 4 months.
  • Uncontrolled infections.
  • Other active cancers with poor prognosis.
  • Positive for HIV or active Hepatitis B or C infections.
  • Liver cirrhosis or active central nervous system disease.
  • Large chloroma or high blast count in bone marrow.
  • Pregnancy or breastfeeding, or unwillingness to use contraception.
  • Participation in another clinical trial within the last 30 days.
  • Any condition or lab result that could affect the study outcome.

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