A Phase 1 Study of SEA-CD70 in Myeloid Malignancies SEA-CD70

What's the purpose of this trial?

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 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 patients with MDS or MDS/AML.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1

Enrollment: 178 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

New Mexico

San Juan Oncology Associates - Four Corners Cancer Center

Farmington, NM

Open and Accepting

New York

Herbert Irving Comprehensive Cancer Center (Columbia University) Columbia University Medical Center

New York, NY

Open and Accepting

Ohio

University Hospitals Seidman Cancer Center Seidman Cancer Center at UH Case Medical

Cleveland, OH

Open and Accepting

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

South Carolina

MUSC Hollings Cancer Center Medical University of South Carolina

Charleston, SC

Open and Accepting

Saint Francis Hospital Cancer Center

Greenville, SC

Open and Accepting

Texas

Texas Oncology (Fort Worth)

Fort Worth, TX

Open and Accepting

Houston Methodist Hospital

Houston, TX

Open and Accepting

Washington

Swedish Cancer Institute - Cherry Hill Campus

Seattle, WA

Open and Accepting
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