For Healthcare Professionals

A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies

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About the study

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have six groups or "parts." - Part A will find out how much SEA-CD70 should be given to patients. - Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with MDS. - Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with AML. - Part D will find out how much SEA-CD70 with azacitidine should be given to patients. - Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS that has not been treated. - Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS or AML.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Participants with cytologically/histologically confirmed MDS according to the 2016 World Health Organization (WHO) classification with the following:
  2. Measurable disease per WHO MDS with excess blasts criteria as defined either:
  3. 5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood or
  4. 10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood
  5. MDS that is relapsed or refractory and must not have other therapeutic options known to provide clinical benefit in MDS available.
  6. Treatment failure after prior hypomethylating agent (HMA) therapy for MDS, defined as one of the following:
  7. Progression (per 2006 International Working Group [IWG] criteria) at any time after initiation of HMA therapy.
  8. Lack of response (failure to achieve complete remission [CR], partial response [PR], or hematologic improvement [HI] per 2006 IWG criteria) after at least 6 cycles of azacitidine (or equivalent HMA) or 4 cycles of decitabine (or equivalent HMA).
  9. Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria).
  10. Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to treatment discontinuation).
  11. Participants with isolated 5q-/5q
  12. syndrome must have progressed, failed, relapsed, or not tolerated lenalidomide in addition to HMA.
  13. Must be off HMA therapy ≥ 2 weeks and must be off any other treatments for MDS for ≥ 4 weeks prior to first dose of SEA-CD70; growth factors and transfusions are allowed before and during the study as clinically indicated
  14. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Part B

EXCLUSION CRITERIA

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall 866-333-7436Email iconEmail Study Center

    Study’s details


    Contition

    Acute Myeloid Leukemia,Myelodyspastic Syndrome

    Age

    18+

    Phase

    Phase 1

    Participants needed

    140

    Est. Completion Date

    Nov 2026

    Treatment type

    Interventional


    Sponsor

    Seagen Inc.

    ClinicalTrials.gov identifier

    NCT04227847

    Study number

    SGNS70-101

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