NC525 for Leukemia

Recruiting at 10 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

28 Participants Needed

Trial Summary

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.

Research Team

Han Myint, MD

Principal Investigator

NextCure, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+