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
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nippon Medical School Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Yamagata University Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Dept. of Medicine, UAB ONeal Comprehensive Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana Farber/Mass General Brigham Cancer Care, Inc Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina- Ashley River Tower Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Hollings Cancer Center Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Medical University of South Carolina- University Hospital Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Medical University of South Carolina- Investigational Drug Services Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University Wexner Medical Center - James Cancer Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Baylor Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Presbyterian/St. Luke's Medical Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Colorado Blood Cancer Institute, Lab Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| IP Address: City of Hope Investigational Drug Services(IDS) Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| The University of Kansas Cancer Center, Investigational Drug Services Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| The University of Kansas - Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Karmanos Cancer Institute Weisberg Cancer Treatment Center Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| The University of Kansas Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| The University of Kansas Cancer Center - Medical Oncology Clinic Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kansas Medical Center Research Institute Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| The University of Kansas Cancer Center - North Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kansas Hospital Cambridge North Tower A Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kansas Medical center Medical office building Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| The University of Kansas Cancer Center - Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Unknown status |
| Ronald Reagan UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Hematology / Oncology Clinic Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Women & Children's Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Norton Hospitals, Inc Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Norton Cancer Institute, St. Matthews Campus Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| The New York and Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| CUIMC Research Pharmacy Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| The University of Kansas Cancer Center - Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| The University of Kansas Cancer Center - Overland Park Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Swedish Cancer Institute Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| The University of Kansas Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.