🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-07-22)

A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies

🟢 Recruiting Phase 1 💊 Investigational Drug / Biologic Sponsor: Seagen, a wholly owned subsidiary of Pfizer

🩺 Protocol Summary

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.

Primary Research Facility: University of Alabama at Birmingham (Birmingham, Alabama)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Myelodysplastic Syndrome?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 18 Years or older?

🔍 Protocol Specified Minimum Age: 18 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 53 Registered Participating Sites

📍 Primary Site Map

Site: University of Alabama at Birmingham — Birmingham, Alabama

📍 All Participating Trial Locations (53 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. University of Alabama at Birmingham — Birmingham, Alabama

2. University of Alabama at Birmingham — Birmingham, Alabama

3. Dept. of Medicine, UAB ONeal Comprehensive Cancer Center — Birmingham, Alabama

4. City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California

5. IP Address: City of Hope Investigational Drug Services(IDS) — Duarte, California

6. Ronald Reagan UCLA Medical Center — Los Angeles, California

7. UCLA Hematology-Oncology Clinic — Los Angeles, California

8. Colorado Blood Cancer Institute, Lab — Denver, Colorado

9. Colorado Blood Cancer Institute — Denver, Colorado

10. Presbyterian/St. Luke's Medical Center — Denver, Colorado

11. The University of Kansas Cancer Center ,Investigational Drug Services — Fairway, Kansas

12. The University of Kansas Clinical Research Center — Fairway, Kansas

13. The University of Kansas Hospital — Kansas City, Kansas

14. University of Kansas Hospital Cambridge North Tower A — Kansas City, Kansas

15. University of Kansas Medical center Medical office building — Kansas City, Kansas

16. University of Kansas Medical Center Research Institute — Kansas City, Kansas

17. The University of Kansas Cancer Center - Overland Park — Overland Park, Kansas

18. The University of Kansas Cancer Center - Indian Creek Campus — Overland Park, Kansas

19. The University of Kansas Cancer Center — Westwood, Kansas

20. Norton Hospitals, Inc — Louisville, Kentucky

21. Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD — Louisville, Kentucky

22. Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky

23. Norton Women & Children's Hospital — Louisville, Kentucky

24. Massachusetts General Hospital — Boston, Massachusetts

25. Beth Israel Deaconess Medical Center — Boston, Massachusetts

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT04227847 • Last Synced: 2026-07-22

View on ClinicalTrials.gov ↗