Actively Recruiting
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 relapsedrefractory MDS and AML dose-finding and expansion of SEA-CD70 combined with azacitidine for relapsedrefractory and untreated higher-risk MDS or MDSAML 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
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
Research Team
P
Pfizer CT.gov Call Center
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