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New drug combo targets tough blood cancers in early trial

NCT ID NCT04227847

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug called SEA-CD70, alone or with standard drugs azacitidine and venetoclax, in people with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The main goal is to check safety and find the right dose. About 178 participants will be enrolled across seven groups. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SEA-CD70 (a drug given intravenously), azacitidine, and venetoclax
What this could lead to
If it works, this could lead to a new treatment option for people with myelodysplastic syndrome or acute myeloid leukemia.
What could go wrong
This is an early phase 1 trial focused on safety, so it is not yet known if SEA-CD70 will effectively treat these cancers. Side effects are possible, and the drug may not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

170 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Myelodysplastic syndrome

Contacts and locations

Locations

  • Baylor Research Institute

    Dallas, Texas, 75204, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CUIMC Research Pharmacy

    New York, New York, 10032, United States

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Colorado Blood Cancer Institute, Lab

    Denver, Colorado, 80218, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Dana Farber/Mass General Brigham Cancer Care, Inc

    Boston, Massachusetts, 02215, United States

  • Dept. of Medicine, UAB ONeal Comprehensive Cancer Center

    Birmingham, Alabama, 35294, United States

  • Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • IP Address: City of Hope Investigational Drug Services(IDS)

    Duarte, California, 91010, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina- Ashley River Tower

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina- Investigational Drug Services

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina- University Hospital

    Charleston, South Carolina, 29425, United States

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207, United States

  • Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD

    Louisville, Kentucky, 40207, United States

  • Norton Hospitals, Inc

    Louisville, Kentucky, 40202, United States

  • Norton Women & Children's Hospital

    Louisville, Kentucky, 40207, United States

  • Pharmacy - UMC Utrecht t.a.v. Apotheek KGO

    Utrecht, 3584 CW, Netherlands

  • Presbyterian/St. Luke's Medical Center

    Denver, Colorado, 80218, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • The New York and Presbyterian Hospital

    New York, New York, 10032, United States

  • The Ohio State University Wexner Medical Center/James Cancer Hospital

    Columbus, Ohio, 43210, United States

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • The University of Kansas Cancer Center ,Investigational Drug Services

    Fairway, Kansas, 66205, United States

  • The University of Kansas Cancer Center - Indian Creek Campus

    Overland Park, Kansas, 66211, United States

  • The University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064, United States

  • The University of Kansas Cancer Center - Medical Oncology Clinic

    Kansas City, Missouri, 64116, United States

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210, United States

  • The University of Kansas Cancer Center -North

    Kansas City, Missouri, 64154, United States

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Hematology-Oncology Clinic

    Los Angeles, California, 90095, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Medical Center (UMC) Utrecht

    Utrecht, 3584 CX, Netherlands

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of Kansas Hospital Cambridge North Tower A

    Kansas City, Kansas, 66160, United States

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160, United States

  • University of Kansas Medical center Medical office building

    Kansas City, Kansas, 66160, United States

  • Yamagata University Hospital

    Yamagata, 990-9585, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.