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NCT04227847Active, not recruitingPhase 1

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

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants 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 seven groups or "parts." * Part A will find out how much SEA-CD70 should be given to participants * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants 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 participants with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to participants * Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is compared to azacitidine alone and if it works to treat participants with MDS or MDS/AML 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 participants with MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
170 (actual)
First submitted
10 Jan 2020
Start date
7 Aug 2020
Primary completion date
4 Jul 2027
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
NCT number
NCT04227847
EU CT number
2023-506945-42-00
EudraCT number
2019-001917-18

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 170
  • From 7 Aug 2020 to the primary completion date, 4 Jul 2027
  • 50 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous exposure to CD70-targeted agents
  • Prior allogeneic hematopoietic stem cell transplant, for any condition
  • 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

Other illness

  • History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura

Other

  • Central nervous system leukemia

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nippon Medical School Hospital
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Bunkyo-kuJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Yamagata University Hospital
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YamagataJapanUnknown status
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, not recruiting
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Dept. of Medicine, UAB ONeal Comprehensive Cancer Center
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BirminghamUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
Dana Farber/Mass General Brigham Cancer Care, Inc
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BostonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Medical University of South Carolina- Ashley River Tower
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CharlestonUnited StatesUnknown status
Hollings Cancer Center
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CharlestonUnited StatesUnknown status
Medical University of South Carolina- University Hospital
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CharlestonUnited StatesUnknown status
Medical University of South Carolina- Investigational Drug Services
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CharlestonUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
The Ohio State University Wexner Medical Center - James Cancer Hospital
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ColumbusUnited StatesUnknown status
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
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DallasUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
Baylor Research Institute
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DallasUnited StatesUnknown status
Presbyterian/St. Luke's Medical Center
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DenverUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
Colorado Blood Cancer Institute, Lab
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DenverUnited StatesUnknown status
Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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DuarteUnited StatesUnknown status
IP Address: City of Hope Investigational Drug Services(IDS)
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DuarteUnited StatesUnknown status
The University of Kansas Cancer Center, Investigational Drug Services
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FairwayUnited StatesUnknown status
The University of Kansas - Clinical Research Center
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FairwayUnited StatesUnknown status
Karmanos Cancer Institute Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
The University of Kansas Hospital
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Kansas CityUnited StatesUnknown status
The University of Kansas Cancer Center - Medical Oncology Clinic
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Kansas CityUnited StatesUnknown status
University of Kansas Medical Center Research Institute
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Kansas CityUnited StatesUnknown status
The University of Kansas Cancer Center - North
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Kansas CityUnited StatesUnknown status
University of Kansas Hospital Cambridge North Tower A
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Kansas CityUnited StatesUnknown status
University of Kansas Medical center Medical office building
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Kansas CityUnited StatesUnknown status
The University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesUnknown status
Ronald Reagan UCLA Medical Center
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Los AngelesUnited StatesUnknown status
UCLA Hematology / Oncology Clinic
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Los AngelesUnited StatesUnknown status
Norton Women & Children's Hospital
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LouisvilleUnited StatesUnknown status
Norton Hospitals, Inc
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LouisvilleUnited StatesUnknown status
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
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LouisvilleUnited StatesUnknown status
Norton Cancer Institute, St. Matthews Campus
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LouisvilleUnited StatesUnknown status
Columbia University Irving Medical Center
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New YorkUnited StatesUnknown status
The New York and Presbyterian Hospital
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New YorkUnited StatesUnknown status
CUIMC Research Pharmacy
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New YorkUnited StatesUnknown status
The University of Kansas Cancer Center - Indian Creek Campus
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Overland ParkUnited StatesUnknown status
The University of Kansas Cancer Center - Overland Park
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Overland ParkUnited StatesUnknown status
Swedish Medical Center
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SeattleUnited StatesUnknown status
Swedish Cancer Institute
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SeattleUnited StatesUnknown status
The University of Kansas Cancer Center
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WestwoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.