What side effects are associated with this type of intervention?

Common treatments for Myelodysplastic Syndrome (MDS) include azacitidine and decitabine. Azacitidine is associated with side effects such as grade 3/4 cytopenias, including neutropenia, thrombocytopenia, and anemia, as well as gastrointestinal symptoms like nausea and vomiting. Decitabine also causes cytopenias and has been noted to improve quality of life measures despite these side effects. Both treatments can lead to increased risk of infections due to myelosuppression. These side effects are important considerations when evaluating the safety and tolerability of new treatments like NC525.

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 and safety profiles. Thrombopoietin receptor agonists like eltrombopag and romiplostim are also under investigation for their potential benefits in MDS, particularly for patients with thrombocytopenia. Additionally, lenalidomide is approved for MDS with del(5q) and is being explored for broader applications. These treatments aim to manage symptoms, improve blood counts, and reduce transfusion needs.

What other types of research exist?

Promising novel alternatives to NC525 for Myelodysplastic Syndrome patients include: 1) Hypomethylating agents such as azacitidine and decitabine, which have shown comparable efficacy and are well-tolerated. 2) Bortezomib combined with low-dose cytarabine, which may improve outcomes in higher-risk MDS patients, especially those with unfavorable karyotypes. 3) Lenalidomide, particularly for patients without del(5q), as it has shown prolonged survival in clinical trials. 4) Homoharringtonine-based protocols, which have been effective and well-tolerated in AML and may be considered for MDS.

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Monoclonal Antibodies

NC525 for Leukemia

Phase 1

Recruiting

Research Sponsored by NextCure, 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 up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called NC525 to see if it is safe and helpful for people with advanced blood cancer. The study focuses on patients with severe forms of myeloid neoplasms. Researchers want to find out if NC525 can improve their condition.

Who is the study for?

Adults over 18 with advanced myeloid neoplasms, specifically relapsed or refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) after treatment failure, or Chronic myelomonocytic leukemia (CMML). Participants must have an ECOG performance status of 0-2 and a life expectancy of at least 12 weeks. They should not be pregnant or planning to conceive and must agree to use contraception.

What is being tested?

The trial is testing the safety, tolerability, and efficacy of NC525 in patients with advanced myeloid neoplasms. It's an open-label, non-randomized Phase 1 study which means everyone gets the drug being tested and there are no placebo groups.

What are the potential side effects?

Specific side effects for NC525 aren't listed but may include typical reactions to immunotherapy such as allergic responses, fatigue, fever, chills, weakness, nausea/vomiting. Since it's a study determining safety/tolerability these will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Define a maximum tolerated dose (MTD) of NC525

Define a minimally active dose (MAD) of NC525

Define a pharmacologically active dose (PAD) of NC525

+3 more

Secondary study objectives

Assessment of time to achieve response, defined as CR, CRi, or CRh

To evaluate the clinical benefit of NC525 by assessing Event-free survival (EFS).

To evaluate the clinical benefit of NC525 by assessing Objective Response (OR).

+1 more

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: NC525Experimental Treatment1 Intervention

Escalating dose levels will be explored.

Do I qualify?Apply below to find out

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, thereby reactivating tumor suppressor genes and inducing cancer cell death. Erythropoiesis-stimulating agents (ESAs) such as erythropoietin boost red blood cell production, alleviating anemia. Thrombopoietin mimetics like romiplostim stimulate platelet production but carry a risk of leukemic transformation. Immunosuppressive therapies, including antithymocyte globulin (ATG) and cyclosporine, modulate the immune system to reduce bone marrow attack. These treatments are crucial for managing MDS symptoms and improving quality of life, but their safety and tolerability must be carefully monitored, as highlighted in studies like the NC525 trial.

SOHO State of the Art and Next Questions: Management of Myelodysplastic Syndromes With Deletion 5q.