28 Participants Needed

NC525 for Leukemia

Recruiting at 10 trial locations
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Do
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Overseen ByDirector Clinical Operations at NextCure, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

HM

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.
See 4 more

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
See 20 more

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?
1Treatment groups
Experimental Treatment
Group I: NC525Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NextCure, Inc.

Lead Sponsor

Trials
8
Recruited
660+
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