Actively Recruiting
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Led by Seagen, a wholly owned subsidiary of Pfizer · Updated on 2026-04-07
178
Participants Needed
54
Research Sites
412 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) confirmed by cytology or histology
- Measurable disease per WHO MDS with excess blasts criteria for MDS parts
- Relapsed or refractory MDS or AML with no other therapeutic options
- Treatment failure after prior hypomethylating agent (HMA) therapy for MDS
- ECOG performance status of 0 to 2
- Eligible for continued therapy with azacitidine (for parts D and F)
- Previously untreated higher-risk MDS or MDS/AML per IPSS-M criteria (for parts D and E)
- Previously untreated AML and ineligible for standard induction chemotherapy (for part G)
You will not qualify if you...
- Previous exposure to CD70-targeted agents
- Prior allogeneic hematopoietic stem cell transplant
- Central nervous system leukemia
- History of significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura
- Prior oral HMA or oral HMA-combinations (for parts D, F, and G only)
- Conditions preventing oral medication use, use of strong/moderate CYP3A inducers, or history of myeloproliferative neoplasm (for part G only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Active, Not Recruiting
3
Dept. of Medicine, UAB ONeal Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Active, Not Recruiting
4
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Actively Recruiting
5
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, United States, 91010
Actively Recruiting
6
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
7
UCLA Hematology-Oncology Clinic
Los Angeles, California, United States, 90095
Actively Recruiting
8
Colorado Blood Cancer Institute, Lab
Denver, Colorado, United States, 80218
Active, Not Recruiting
9
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Active, Not Recruiting
10
Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States, 80218
Active, Not Recruiting
11
The University of Kansas Cancer Center ,Investigational Drug Services
Fairway, Kansas, United States, 66205
Actively Recruiting
12
The University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
13
The University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
14
University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States, 66160
Actively Recruiting
15
University of Kansas Medical center Medical office building
Kansas City, Kansas, United States, 66160
Actively Recruiting
16
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160
Actively Recruiting
17
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
18
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
19
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
20
Norton Hospitals, Inc
Louisville, Kentucky, United States, 40202
Actively Recruiting
21
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
Louisville, Kentucky, United States, 40207
Actively Recruiting
22
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States, 40207
Actively Recruiting
23
Norton Women & Children's Hospital
Louisville, Kentucky, United States, 40207
Actively Recruiting
24
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
26
Dana Farber/Mass General Brigham Cancer Care, Inc
Boston, Massachusetts, United States, 02215
Actively Recruiting
27
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
28
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
29
The University of Kansas Cancer Center - Medical Oncology Clinic
Kansas City, Missouri, United States, 64116
Actively Recruiting
30
The University of Kansas Cancer Center - Radiation Oncology Clinic
Kansas City, Missouri, United States, 64116
Actively Recruiting
31
The University of Kansas Cancer Center -North
Kansas City, Missouri, United States, 64154
Actively Recruiting
32
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
33
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
34
CUIMC Research Pharmacy
New York, New York, United States, 10032
Actively Recruiting
35
The New York and Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
36
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
37
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
38
The Ohio State University Wexner Medical Center/James Cancer Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
39
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
40
Medical University of South Carolina- Ashley River Tower
Charleston, South Carolina, United States, 29425
Actively Recruiting
41
Medical University of South Carolina- Investigational Drug Services
Charleston, South Carolina, United States, 29425
Actively Recruiting
42
Medical University of South Carolina- University Hospital
Charleston, South Carolina, United States, 29425
Actively Recruiting
43
Baylor Research Institute
Dallas, Texas, United States, 75204
Actively Recruiting
44
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas, Texas, United States, 75246
Actively Recruiting
45
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
46
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
47
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
48
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
49
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
50
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
51
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
52
Yamagata University Hospital
Yamagata, Japan, 990-9585
Actively Recruiting
53
Pharmacy - UMC Utrecht t.a.v. Apotheek KGO
Utrecht, Netherlands, 3584 CW
Actively Recruiting
54
University Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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