What side effects are associated with this type of intervention?

Common treatments for Myelodysplastic Syndrome (MDS) include thrombopoietin mimetics, demethylating agents like azacitidine and decitabine, and monoclonal antibodies such as JSP191 (anti-CD117). Thrombopoietin mimetics can increase the risk of progression to acute myeloid leukemia (AML) and may cause bone marrow fibrosis. Demethylating agents are associated with side effects like pancytopenia, infection, liver toxicity, and neuropathy. Monoclonal antibodies, including anti-CD117, may cause infusion-related reactions, cytopenias, and increased susceptibility to infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Myelodysplastic Syndrome (MDS). Hypomethylating agents such as azacitidine and decitabine are commonly used and have shown comparable efficacy in treating MDS. Lenalidomide is another approved drug, particularly effective in patients with del(5q) MDS. Thrombopoietin receptor agonists like eltrombopag and romiplostim are under investigation for their potential benefits in thrombocytopenic patients with MDS, although they are not routinely recommended due to concerns about leukemic transformation. JSP191, an anti-CD117 monoclonal antibody, represents a novel approach currently being studied for its safety and efficacy in lower-risk MDS.

What other types of research exist?

Promising novel alternatives to JSP191 for Myelodysplastic Syndrome (MDS) patients include hypomethylating agents (HMAs) such as azacitidine and decitabine, which have shown comparable efficacy and tolerability. Additionally, therapies like lenalidomide, particularly in combination with other agents, and emerging monoclonal antibodies targeting specific mutations (e.g., IDH1/IDH2 inhibitors) are also considered promising. Gemtuzumab ozogamicin, an anti-CD33 antibody conjugate, is another potential option for certain MDS patients.

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JSP191 for Myelodysplastic Syndrome

Phase 1

Recruiting

Research Sponsored by Jasper Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called JSP191 to see if it is safe and effective for patients with Low-Risk Myelodysplastic Syndromes who need regular blood transfusions or have low blood cell counts. The goal is to find out if JSP191 can improve their blood cell counts and reduce their need for transfusions.

Who is the study for?

This trial is for adults over 18 with low to intermediate-risk Myelodysplastic Syndrome (MDS) who have symptoms like anemia or bleeding. Women able to have children must use effective birth control, and men too, during the study and for 3 months after. Participants need to understand and agree to the study's requirements.

What is being tested?

The trial is testing JSP191 (Briquilimab) as a second-line treatment for MDS. It's in Phase 1, which means it's early in testing and focuses on how safe it is and what doses are tolerable when given to people.

What are the potential side effects?

Since this is a Phase 1 trial primarily assessing safety, specific side effects of JSP191 aren't listed but may include typical drug reactions such as nausea, fatigue, allergic responses or more serious effects depending on individual patient response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and tolerability of JSP191

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: JSP191Experimental Treatment1 Intervention

This study will explore up to 5 ascending dose levels (Cohorts 1, 2, 3, 4, and 5) and subjects will receive JSP191 on Day 1 on each 8-week cycle for 4 consecutive cycles.

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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 hypomethylating agents like azacitidine and decitabine, which work by inhibiting DNA methylation, leading to the reactivation of tumor suppressor genes and promoting normal cell differentiation. Lenalidomide, particularly effective in patients with del(5q) MDS, modulates the immune response and promotes the destruction of malignant cells. Thrombopoietin mimetics, such as romiplostim, stimulate platelet production but carry a risk of leukemic transformation. JSP191, an anti-CD117 monoclonal antibody, targets the CD117 receptor on hematopoietic stem cells, potentially clearing malignant cells and allowing for healthy stem cell repopulation. Understanding these mechanisms is crucial for MDS patients as it helps tailor treatments to their specific disease characteristics and risks, improving outcomes and quality of life.

SOHO State of the Art and Next Questions: Management of Myelodysplastic Syndromes With Deletion 5q.Lenalidomide as a disease-modifying agent in patients with del(5q) myelodysplastic syndromes: linking mechanism of action to clinical outcomes.Combination therapy with DNA methyltransferase inhibitors in hematologic malignancies.