A Phase 1 interventional study of SEA-CD70 and azacitidine in Myelodysplastic Syndrome and Acute Myeloid Leukemia, sponsored by Seagen, a wholly owned subsidiary of Pfizer. Active, not recruiting at 52 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Seagen, a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 1, Interventional, and Treatment
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."
This is a phase 1, open-label, multicenter, dose-finding, and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SEA-CD70 monotherapy and SEA-CD70 in combination with azacitidine in adults with myeloid malignancies. The study will be conducted in up to 6 parts.
2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 319 are open to participants now.
This study's enrollment of 170 is above the median of 39 across 1,740 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Seagen, a wholly owned subsidiary of Pfizer is the lead sponsor of 30 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.
First submitted before Seagen became part of Pfizer.
Counted across the registry records on this site, refreshed daily.
Part A Inclusion Criteria
Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with
Part B Inclusion Criteria
Participants with cytologically/histologically confirmed MDS (WHO classification) with:
Part C Inclusion Criteria
Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia [APL]):
Who have received 1 previous regimen to treat active disease and have at least one of the following:
Parts D and F Inclusion Criteria
Parts D and E Inclusion Criteria
Part G Inclusion Criteria
Exclusion Criteria (All Parts)
SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS
Drug: SEA-CD70
SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS
Drug: SEA-CD70
SEA-CD70 expansion cohort in relapsed/refractory AML
Drug: SEA-CD70
SEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML
Drug: SEA-CD70 · Drug: azacitidine
SEA-CD70 + azacitidine vs azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML
Drug: SEA-CD70 · Drug: azacitidine
SEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML
Drug: SEA-CD70 · Drug: azacitidine
SEA-CD70 + azacitidine +venetoclax dose-finding/dose optimization in previously untreated and unfit for induction therapy AML
Drug: SEA-CD70 · Drug: azacitidine · Drug: Venetoclax
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle
75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.
Also known as: VIDAZA
400 mg /day PO, continuously; administered with ramping
Also known as: Venclexta
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Number of participants with laboratory abnormalities
To be summarized using descriptive statistics.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)
To be summarized using descriptive statistics.
Time frame: Though end of DLT evaluation period; up to approximately 4 weeks
AUC - Area under the plasma concentration-time curve
To be summarized using descriptive statistics.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Tmax - Time to maximum concentration attained
To be summarized using descriptive statistics.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Cmax - Maximum observed plasma concentration
To be summarized using descriptive statistics.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Ctrough - Minimum plasma concentration per dosing interval
To be summarized using descriptive statistics.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
T1/2 - Terminal elimination half-life
To be summarized using descriptive statistics.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Incidence of antidrug antibodies (ADA)
To be summarized using descriptive statistics.
Time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Complete remission (CR) Rate and complete remission equivalent (CReq) rate
Proportion of participants with AML, MDS/AML or MDS who achieve CR or CReq
Time frame: Up to approximately 4 years
Complete remission with incomplete blood count recovery (CRi) rate
Proportion of participants with AML who achieve CRi
Time frame: Up to approximately 4 years
Complete remission with limited count recovery (CRL) rate for participants with MDS or MDS/AML
Proportion of participants with MDS or MDS/AML who achieve CRL
Time frame: Up to approximately 4 years
Complete remission with partial hematologic recovery (CRh) rate
Proportion of participants with AML, MDS/AML, or MDS who achieve CRh
Time frame: Up to approximately 4 years
Hematologic response (HI) rate
Proportion of participants with MDS or MDS/AML with HI
Time frame: Up to approximately 4 years
Overall response rate (ORR)
For AML, the proportion of participants who achieve a best response of CR, CRi, CRh, or partial response (PR). For MDS, the proportion of participants who achieve a best response of CR, CReq, CRL, CRh, PR, or HI
Time frame: Up to approximately 4 years
Duration of remission (DOR)
For AML, the time from first CR/CRi/CRh/PR response to the first documentation of disease progression, start of new anticancer therapy, or death due to any cause. For MDS, the time from first CR (or Req)/CRL/CRh/PR to the first documentation of disease progression, start of new anticancer therapy, or death due to any cause
Time frame: Up to approximately 4 years
Overall survival (OS)
Time from start of study treatment to the date of death due to any cause
Time frame: Up to approximately 4 years
Event-free survival (EFS)
Time from first dose to the first documentation of progression, failure to achieve remission within 6 months of study entry, disease relapse, or death due to any cause, whichever comes first.
Time frame: Up to approximately 4 years
Progression-free survival (PFS)
Time from first dose to the first documentation of progression, disease relapse, or death from any cause, whichever comes first
Time frame: Up to approximately 4 years
MRD-negative ORR
Proportion of participants with AML or MDS who achieve MRD-negative ORR
Time frame: Up to approximately 4 years
Time to response (TTR)
Time from start of study treatment to the first documentation of objective response
Time frame: Up to approximately 4 years
Rate of conversion to transfusion independence (TI)
Proportion of participants who convert from transfusion dependence at baseline to TI post-baseline
Time frame: Up to approximately 4 years
Rate of TI maintenance
Proportion of participants who were TI at baseline and maintain TI post-baseline
Time frame: Up to approximately 4 years
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Seagen, a wholly owned subsidiary of Pfizer→