NC525 for Leukemia

No longer recruiting at 11 trial locations

Overseen By Director Clinical Operations at NextCure, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NextCure, Inc.

Must not be taking: Calcineurin inhibitors, Steroids

Disqualifiers: CNS pathology, Active CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NC525, to determine its safety and effectiveness for people with advanced myeloid neoplasms, a group of blood cancers including leukemia and similar conditions. The study explores different dose levels to find the best balance between safety and effectiveness. It seeks participants with specific types of these blood cancers, such as relapsed or treatment-resistant AML or MDS, who haven't had success with other treatments. This trial might suit individuals whose condition has returned or isn't responding to standard therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the NC525 trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.

Is there any evidence suggesting that NC525 is likely to be safe for humans?

Research has shown that NC525 significantly stopped leukemia growth in animal tests, suggesting potential effectiveness against leukemia. However, as a Phase 1 trial, the primary goal is to determine if NC525 is safe and well-tolerated in humans. Phase 1 indicates the first testing of the treatment in people, so limited human safety data exists. This phase will identify any side effects and assess the treatment's tolerability in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard leukemia treatments that often focus on chemotherapy or targeted therapies like tyrosine kinase inhibitors, NC525 is unique because it explores escalating dose levels to potentially enhance effectiveness. Researchers are excited about this treatment because it could offer a new approach to tackling leukemia by adjusting doses to optimize patient response. This experimental method may provide a more personalized treatment option, potentially minimizing side effects while maximizing efficacy.

What evidence suggests that NC525 might be an effective treatment for leukemia?

Research has shown that NC525, the investigational treatment in this trial, yields promising results in treating leukemia. Studies have found that NC525 can completely stop leukemia from spreading in lab models, suggesting it might eliminate cancerous stem cells. NC525 targets a protein called LAIR-1, blocking pathways that cancer cells use to survive. This action slows the growth of acute myeloid leukemia (AML) cells while allowing healthy blood cells to grow normally. Early findings suggest that NC525 could be a powerful tool against advanced myeloid neoplasms by directly killing cancer cells. ^{1 2 4 6 7}

Who Is on the Research Team?

Han Myint, MD

Principal Investigator

NextCure, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a relapsed or refractory form of AML, MDS, or CMML.

I am a male and agree to use contraception and not donate sperm for 90 days after treatment.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

I have lasting side effects from a bone marrow transplant.

Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or 5 half-lives prior to the first dose of study treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of NC525 to determine safety, tolerability, and efficacy

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NC525

Trial Overview 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.

How Is the Trial Designed?

Group I: NC525 Experimental Treatment 1 Intervention

Escalating dose levels will be explored.

Who Is Running the Clinical Trial?

NextCure, Inc.

Lead Sponsor

Trials

8

Recruited

660+

Citations

1. ashpublications.org ashpublications.org/blood/article/140/Supplement%201/9078/491766/A-Phase-1-Open-Label-Safety-Tolerability-and

A Phase 1, Open-Label, Safety, Tolerability, and Efficacy ... Finally, NC525 completely inhibits leukemia propagation in secondary transplant models, suggesting that NC525 is capable of eradicating LSCs.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05787496

NCT05787496 | A Safety, Tolerability and Efficacy Study of ... This is an open-label, non-randomized, Phase 1 study to determine the safety and tolerability of NC525. This study will also assess the clinical benefit in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10650974/

LAIR-1 agonism as a therapy for acute myeloid leukemia - PMC These findings suggested that NC525 suppressed survival pathways ... Data showed that NC525 significantly suppressed mTOR activity and ...

4. ir.nextcure.com ir.nextcure.com/news-releases/news-release-details/nextcure-present-trial-progress-poster-nc525-2022-american

NextCure to Present Trial in Progress Poster for NC525 at the ... “At last year's ASH conference, we shared promising preclinical data on NC525 ... Efficacy Study of NC525 in Subjects with Advanced Myeloid ...

5. synapse.patsnap.com synapse.patsnap.com/article/targeting-lair-1-with-nc525-a-promising-approach-for-advanced-myeloid-neoplasms-treatment

Targeting LAIR-1 with NC525: A Promising Approach for ... It has shown the ability to inhibit the growth of AML cells, spare the formation and differentiation of healthy HSCs, and directly kill AML ...

6. ir.nextcure.com ir.nextcure.com/news-releases/news-release-details/nextcure-publishes-non-clinical-data-defining-mechanism-action

NextCure Publishes Non-Clinical Data Defining the ... The data demonstrate that NC525 induces cell death in acute myeloid leukemia ... safety and tolerability of NC525 in adult patients with ...

7. ir.nextcure.com ir.nextcure.com/static-files/cd5b22bc-1e2f-4025-aa38-fa0cad2663e1

A Phase 1, Open-Label, Safety, Tolerability, and Efficacy ... We developed a LAIR-1 agonist monoclonal antibody (mAb), termed NC525, that clusters LAIR-1 in the presence of endogenous ligands, increasing programmed cell ...