What side effects are associated with this type of intervention?

Common treatments for Myelodysplastic Syndrome (MDS) include erythropoiesis-stimulating agents (ESAs), thrombopoietin receptor agonists, and newer agents like luspatercept. ESAs can cause hypertension and increase the risk of thromboembolic events. Thrombopoietin receptor agonists, such as romiplostim, may transiently improve platelet counts but have been associated with an increased risk of progression to acute myeloid leukemia (AML) and bone marrow fibrosis. Luspatercept, approved for certain MDS patients, can cause fatigue, diarrhea, and dizziness. KER-050, an activin receptor type IIA ligand trap, aims to promote erythropoiesis, and while specific side effects are still under study, similar agents have shown potential risks of hypertension and thromboembolic events.

What prior FDA approvals exist?

The FDA has approved several treatments for Myelodysplastic Syndrome (MDS) that promote erythropoiesis. Erythropoiesis-stimulating agents (ESAs) like epoetin alfa and darbepoetin alfa are commonly used to manage anemia in MDS patients. Additionally, hypomethylating agents such as azacitidine and decitabine are approved for MDS and have shown efficacy in improving hematologic function. Thrombopoietin receptor agonists like eltrombopag have also been evaluated for their potential benefits in MDS, particularly for thrombocytopenic patients. These treatments aim to improve blood cell counts and reduce the need for transfusions.

What other types of research exist?

Promising alternatives to KER-050 for MDS patients include erythropoiesis-stimulating agents (ESAs) like epoetin alfa and darbepoetin alfa, which have shown efficacy in reducing the need for RBC transfusions and improving hemoglobin levels. Additionally, thrombopoietin mimetics such as romiplostim may be considered for patients with thrombocytopenia, although they carry some risks. Clinical trials and emerging therapies should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Erythropoiesis-Stimulating Agent

KER-050 for Anemia in Myelodysplastic Syndromes

Phase 2

Recruiting

Research Sponsored by Keros Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease

Be older than 18 years old

Must not have

Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept

Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from treatment initiation to end of study, approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing KER-050, a protein treatment, on patients with low-risk MDS who have low blood cell counts. KER-050 helps the body produce more red blood cells and platelets by blocking signals that slow down their production.

Who is the study for?

This trial is for patients with very low to intermediate risk Myelodysplastic Syndromes (MDS) who have anemia. They should not have had recent infections, vitamin deficiencies, or certain treatments like chemotherapy. Participants need a specific white blood cell count and bone marrow blast percentage, and must agree to use contraception if applicable.

What is being tested?

The study tests KER-050's effectiveness on anemia in MDS patients at various risk levels. It aims to see how well the drug improves red blood cell counts without transfusions or if it reduces the need for them in those already receiving transfusions.

What are the potential side effects?

While specific side effects of KER-050 are not listed here, common side effects for drugs treating MDS may include fatigue, nausea, bruising or bleeding more easily due to low platelet counts, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is a type of blood cancer classified as low to intermediate risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific medications like azacitidine or lenalidomide.

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I have taken Vitamin B12 within the last 8 weeks.

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I have not taken any blood cell growth boosters in the last 28 days.

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I haven't needed IV antibiotics in the last 28 days or oral antibiotics in the last 14 days.

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My kidney function is low, with a GFR less than 40 mL/min.

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My MDS was caused by previous cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from treatment initiation to end of study, approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from treatment initiation to end of study, approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment initiation to end of study, approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs) and serious adverse events (SAEs).

Secondary study objectives

Change from Baseline in RBC counts and reticulocytes

Duration of erythroid response and modified 2006 IWG HI-E response

Erythroid response in low-transfusion burden (LTB) and high-transfusion burden (HTB) participants.

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: KER-050 Dose Confirmation CohortExperimental Treatment1 Intervention

Participants to receive KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.

Group II: KER-050 Cohort 5Experimental Treatment1 Intervention

Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.

Group III: KER-050 Cohort 4Experimental Treatment1 Intervention

Group IV: KER-050 Cohort 3Experimental Treatment1 Intervention

Group V: KER-050 Cohort 2Experimental Treatment1 Intervention

Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 4 cycles. Participants have the option to continue to receive KER-050 once 4 cycles have been completed for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.

Group VI: KER-050 Cohort 1Experimental Treatment1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Myelodysplastic Syndrome (MDS) include erythropoiesis-stimulating agents (ESAs), hypomethylating agents, and thrombopoietin receptor agonists. ESAs, such as epoetin alfa and darbepoetin alfa, stimulate red blood cell production, addressing anemia in MDS patients. Hypomethylating agents like azacitidine and decitabine work by inhibiting DNA methylation, which can restore normal function to genes that control cell growth and differentiation. Thrombopoietin receptor agonists, such as romiplostim, increase platelet production but have potential risks like promoting leukemic transformation. Treatments like KER-050, an Activin Receptor Type IIA Ligand Trap, specifically promote erythropoiesis, which is crucial for managing anemia in MDS patients. These mechanisms are vital as they directly address the hematologic deficiencies in MDS, improving patients' quality of life and potentially delaying disease progression.

TLR7 ligation augments hematopoiesis in Rps14 (uS11) deficiency via paradoxical suppression of inflammatory signaling.Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS).Differential effects of nitrostyrene derivatives on myelopoiesis involve regulation of C/EBPα and p38MAPK activity.