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Safety evaluation of SEA-CD70 in patients with myeloid malignancies

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Phase 1 Interventional Seagen Inc. · NCT04227847

This study is testing a new drug called SEA-CD70, alone and with another medication, to see if it can safely help people with myelodysplastic syndrome and acute myeloid leukemia.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment178 (estimated)
Ages18 Years and up
SexAll
SponsorSeagen Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations54 sites (Birmingham, Alabama and 53 other locations)
Trial IDNCT04227847 on ClinicalTrials.gov

What this trial studies

This trial investigates the safety and efficacy of a drug called SEA-CD70, both alone and in combination with azacitidine, for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). The study is structured into multiple parts, including dose-finding and expansion cohorts, to determine the maximum tolerated dose and assess the drug's effects on these malignancies. Participants will be monitored for side effects and overall response to treatment. The trial aims to provide insights into the pharmacokinetics and antitumor activity of SEA-CD70 in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults with relapsed or refractory MDS or AML who have limited treatment options.

Not a fit: Patients with acute promyelocytic leukemia or those who have not previously failed hypomethylating agent therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with difficult-to-treat myeloid malignancies.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Part A Inclusion Criteria

* Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with

  * Measurable disease per WHO MDS with excess blasts criteria
  * MDS that is relapsed or refractory and must not have other therapeutic options
  * Treatment failure after prior hypomethylating agent (HMA) therapy for MDS
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Part B Inclusion Criteria

* Participants with cytologically/histologically confirmed MDS (WHO classification) with:

  * Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria
  * MDS that is relapsed or refractory and must not have other therapeutic options
  * Treatment failure after prior HMA therapy for MDS
* ECOG Performance Status of 0-2

Part C Inclusion Criteria

* Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \[APL\]):

  * Who have received either 2 or 3 previous regimens
  * Who have received 1 previous regimen to treat active disease and have at least one of the following:

    * Age \> 60 and ≤75 years.
    * Primary resistant AML or secondary AML
    * First CR duration \<6 months
    * Adverse-risk per European Leukemia Network genetic risk stratification
* Age 18-75 years
* ECOG performance status of 0-2

Parts D and F Inclusion Criteria

* Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria)
* Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.
* Eligible for continued therapy with azacitidine
* ECOG Performance Status 0-2

Parts D and E Inclusion Criteria

* Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria), previously untreated.
* Participants with higher-risk per IPSS-M MDS and MDS/AML
* ECOG Performance Status 0-2

Part G Inclusion Criteria

* Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy.
* Age ≥18 years.
* ECOG Performance Status of 0-2.

Exclusion Criteria (All Parts)

* Previous exposure to CD70-targeted agents
* Prior allogeneic hematopoietic stem cell transplant, for any condition
* Central nervous system leukemia
* History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura
* Parts D, F and G only: Prior oral HMA or oral HMA-combinations
* Part G: conditions that preclude enteral route of administration; concomitant use of strong/moderate CYP3A inducers; history of myeloproliferative neoplasm

Where this trial is running

Birmingham, Alabama and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myelodysplastic SyndromeAcute Myeloid LeukemiaSeattle Genetics
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.