A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies (NCT04227847)
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham โ Birmingham, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (53 Sites)
Showing the first 25 of 53 sites.
- University of Alabama at Birmingham โ Birmingham, Alabama
- University of Alabama at Birmingham โ Birmingham, Alabama
- Dept. of Medicine, UAB ONeal Comprehensive Cancer Center โ Birmingham, Alabama
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) โ Duarte, California
- IP Address: City of Hope Investigational Drug Services(IDS) โ Duarte, California
- Ronald Reagan UCLA Medical Center โ Los Angeles, California
- UCLA Hematology-Oncology Clinic โ Los Angeles, California
- Colorado Blood Cancer Institute, Lab โ Denver, Colorado
- Colorado Blood Cancer Institute โ Denver, Colorado
- Presbyterian/St. Luke's Medical Center โ Denver, Colorado
- The University of Kansas Cancer Center ,Investigational Drug Services โ Fairway, Kansas
- The University of Kansas Clinical Research Center โ Fairway, Kansas
- The University of Kansas Hospital โ Kansas City, Kansas
- University of Kansas Hospital Cambridge North Tower A โ Kansas City, Kansas
- University of Kansas Medical center Medical office building โ Kansas City, Kansas
- University of Kansas Medical Center Research Institute โ Kansas City, Kansas
- The University of Kansas Cancer Center - Overland Park โ Overland Park, Kansas
- The University of Kansas Cancer Center - Indian Creek Campus โ Overland Park, Kansas
- The University of Kansas Cancer Center โ Westwood, Kansas
- Norton Hospitals, Inc โ Louisville, Kentucky
- Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD โ Louisville, Kentucky
- Norton Cancer Institute, St. Matthews Campus โ Louisville, Kentucky
- Norton Women & Children's Hospital โ Louisville, Kentucky
- Massachusetts General Hospital โ Boston, Massachusetts
- Beth Israel Deaconess Medical Center โ Boston, Massachusetts
๐ Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.