OncoMatch/Clinical Trials/NCT04227847
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Is NCT04227847 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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 →Frequently asked questions
Is NCT04227847 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD70-targeted agent, allogeneic hematopoietic stem cell transplant, oral hypomethylating agent or oral HMA-combinations disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify