Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models.
Jonatan Dewulf, Tal Flieswasser, Tim Delahaye...
https://pubmed.ncbi.nlm.nih.gov/37093350Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID04227847
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies Evaluating Safety and Dosing with Azacitidine and Venetoclax
Led by Seagen, a wholly owned subsidiary of Pfizer · Updated on 2026-04-07
178
Participants Needed
54
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a drug called SEA-CD70, alone and combined with azacitidine, to assess its safety and potential effects in adults with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). This phase 1, open-label study aims to find appropriate dosing and understand side effects and antitumor activity in participants with relapsed or refractory disease as well as previously untreated higher-risk cases. The trial is sponsored by Seagen, a subsidiary of Pfizer, and includes several parts to address different patient groups and treatment combinations. The study consists of seven parts: dose escalation and expansion of SEA-CD70 monotherapy for relapsed/refractory MDS and AML; dose-finding and expansion of SEA-CD70 combined with azacitidine for relapsed/refractory and untreated higher-risk MDS or MDS/AML; and dose-finding of SEA-CD70 with azacitidine and venetoclax in untreated AML patients unfit for standard chemotherapy. SEA-CD70 is given intravenously on Days 1 and 15 of each treatment cycle, azacitidine is given either subcutaneously or intravenously on Days 1 through 7, and venetoclax is taken orally daily with dose ramping. Participants will undergo safety and tolerability assessments, laboratory tests, and pharmacokinetic analyses through approximately two years after the last dose. Researchers will monitor adverse events, dose-limiting toxicities, and laboratory abnormalities. Secondary measures include response rates, remission durations, survival rates, and drug concentration levels. The study evaluates how well participants tolerate the treatments and examines the drugs' effects on disease progression over up to four years.
CONDITIONS
Brief Title
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Who Can Participate
Age: 18Years +
All Genders
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
- MDS with measurable disease and relapsed or refractory after prior hypomethylating agent (HMA) therapy
- ECOG performance status of 0 to 2
- For relapsed/refractory AML: 2 or 3 prior treatment regimens, or 1 prior regimen with additional risk factors
- Previously untreated higher-risk MDS or MDS/AML per IPSS-M criteria (Parts D and E)
- Eligible for azacitidine therapy when combined treatment is planned
- Previously untreated AML participants who are unfit for standard induction chemotherapy (Part G)
You will not qualify if you...
- Previous treatment with 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
- For Parts D, F, and G: prior oral hypomethylating agents or oral HMA combinations
- For Part G: conditions preventing oral drug administration, use of strong/moderate CYP3A inducers, or history of myeloproliferative neoplasm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated cycles until disease progression or discontinuation
Participants receive SEA-CD70 alone or in combination with azacitidine, and for some, also with venetoclax. SEA-CD70 is given intravenously on Days 1 and 15 of each treatment cycle. Azacitidine is administered subcutaneously or intravenously on Days 1 through 7 of each cycle. Venetoclax, when used, is taken orally daily with dose ramping.
Visits on Days 1 and 15 of each cycle; additional visits for azacitidine administration on Days 1 through 7; venetoclax taken daily
Follow-up
Duration - Up to approximately 2 years after last dose
Participants are monitored for safety and response after ending treatment, including adverse events and laboratory assessments.
Periodic visits for up to 2 years following last dose
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
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Research Team
P
Pfizer CT.gov Call Center
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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