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A Phase 1, Open-Label, Safety, Tolerability, and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms

Clinical Trial Details

This clinical trial is for adult participants who have advanced blood cancer that has been previously treated and is now unresponsive.
   
The purpose of this study is to learn more about the safety and effectiveness of using an investigational drug, NC525, in the treatment of blood cancer. An “Investigational” drug means it has not been approved for marketing by any health authority including the U.S. Food and Drug Administration (FDA).
   
Participants will be asked to complete the following research procedures: take the study drug, NC525; provide information related to previous medical and social history; undergo complete physical exams including vital signs; and provide blood and bone marrow samples.
   
The study agent NC525 will be administered via infusion into a participant's vein. Participants will receive the infusion weekly during the first 2 cycles and every two weeks for each cycle after that. Each cycle will last 28 days.
   
Participation will last up to approximately two years or until a participant’s disease progresses or they experience side effects that require treatment to be stopped. If a participant decides to discontinue study treatment, they will be asked to continue to participate in safety follow-up procedures and to allow the research team to continue to utilize their medical information.

Key Eligibility: 

Adults with one of the following Myeloid Neoplasms determined by pathology review at the treating institution: 
   • Relapsed or Refractory acute myeloid leukemia (AML)
   • Relapsed or Refractory Myelodysplastic syndrome (MDS) after prior hypomethylating agents
   • Relapsed or Refractory Chronic myelomonocytic leukemia (CMML) with progressive disease or lack of response to hypomethylating agents
   
Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2303025802

ClinicalTrials.gov:

NCT05787496

Sponsor:

NC525-01

Status

Open to Enrollment

Age Group

Adult

Sponsor