OncoMatch/Clinical Trials/NCT04227847
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Is NCT04227847 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including SEA-CD70 and azacitidine for myelodysplastic syndrome.
Treatment: SEA-CD70 · azacitidine · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent — MDS or MDS/AML, relapsed/refractory
Treatment failure after prior hypomethylating agent (HMA) therapy for MDS; Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy
Cannot have received: CD70-targeted agent
Previous exposure to CD70-targeted agents
Cannot have received: allogeneic hematopoietic stem cell transplant
Prior allogeneic hematopoietic stem cell transplant, for any condition
Cannot have received: oral hypomethylating agent or oral HMA-combinations
Exception: Parts D, F and G only
Parts D, F and G only: Prior oral HMA or oral HMA-combinations
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- University of Alabama at Birmingham · Birmingham, Alabama
- Dept. of Medicine, UAB ONeal Comprehensive Cancer Center · Birmingham, Alabama
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) · Duarte, California
- IP Address: City of Hope Investigational Drug Services(IDS) · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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