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Tests treatment safety and results for Myelodysplastic Syndrome
Official title A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
ClinicalTrials.gov ID: NCT04227847
What this study is testing
What is SEA-CD70?
SEA-CD70 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myelodysplastic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with
- Measurable disease per WHO MDS with excess blasts criteria
- MDS that is relapsed or refractory and must not have other therapeutic options
- Treatment failure after prior hypomethylating agent (HMA) therapy for MDS
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Part B Participants with cytologically/histologically confirmed MDS (WHO...
You likely can't join if
- (All Parts)
- Previous exposure to CD70-targeted agents
- Prior allogeneic hematopoietic stem cell transplant, for any condition
- Central nervous system leukemia
- History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura
- Parts D, F and G only: Prior oral HMA or oral HMA-combinations
See the full eligibility criteria
- Part A Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with
- Measurable disease per WHO MDS with excess blasts criteria
- MDS that is relapsed or refractory and must not have other therapeutic options
- Treatment failure after prior hypomethylating agent (HMA) therapy for MDS
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Part B Participants with cytologically/histologically confirmed MDS (WHO classification) with:
- Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria
- MDS that is relapsed or refractory and must not have other therapeutic options
- Treatment failure after prior HMA therapy for MDS
- ECOG Performance Status of 0-2 Part C Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia [APL]):
- Who have received either 2 or 3 previous regimens
- Who have received 1 previous regimen to treat active disease and have at least one of the following:
- Age \> 60 and ≤75 years.
- Primary resistant AML or secondary AML
- First CR duration \<6 months
- Adverse-risk per European Leukemia Network genetic risk stratification
- Age 18-75 years
- ECOG performance status of 0-2 Parts D and F Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria)
- Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.
- Eligible for continued therapy with azacitidine
- ECOG Performance Status 0-2 Parts D and E Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria), previously untreated.
- Participants with higher-risk per IPSS-M MDS and MDS/AML
- ECOG Performance Status 0-2 Part G Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy.
- Age ≥18 years.
- ECOG Performance Status of 0-2.
- (All Parts)
- Previous exposure to CD70-targeted agents
- Prior allogeneic hematopoietic stem cell transplant, for any condition
- Central nervous system leukemia
- History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura
- Parts D, F and G only: Prior oral HMA or oral HMA-combinations
- Part G: conditions that preclude enteral route of administration; concomitant use of strong/moderate CYP3A inducers; history of myeloproliferative neoplasm
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Farmington Hills, Michigan, United States
- Kansas City, Missouri, United States
- Lee's Summit, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; Fairway, Kansas, United States; Kansas City, Kansas, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.