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MPN Clinical Trial Finder

Clinical Trial Finder

Search Results

A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms

Study Purpose

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 subjects with advanced myeloid neoplasms.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The subject is willing to provide written informed consent for the trial. 2. Be ≥ 18 years of age on the day of signing informed consent. 3. Subject has one of the following Myeloid Neoplasms determined by pathology review at the treating institution: 1. Relapsed or Refractory AML, Note: Active, relapsed, or refractory AML is defined as any one of the following:
  • - Primary induction failure, or (PIF) after 2 or more cycles of therapy, - First early relapse after a remission duration of fewer than 6 months, - Relapse refractory to salvage combination chemotherapy second or subsequent relapse, or.
  • - Relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood.
2. Relapsed or Refractory Myelodysplastic syndrome (MDS) after prior hypomethylating agents. Note: Subject must have sub-type MDS-EB2 with 10-19% blasts by bone marrow biopsy or aspirate. 3. Relapsed or Refractory Chronic myelomonocytic leukemia (CMML) with progressive disease or lack of response to hypomethylating agents. 4. A male subject must agree to use approved contraception (based on institutional guidelines) and refrain from sperm donation or expecting to father a child, from Screening through the treatment period and for at least 90 days after the last dose of study treatment. 5. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP); 2. A WOCBP agrees to follow approved contraceptive guidance (based on institutional guidelines) from Screening through the treatment period and for at least 90 days after the last dose of study treatment. 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Life expectancy greater than or equal to 12 weeks as judged by the Investigator. 8. Have adequate organ function as defined in the protocol.

Exclusion Criteria:

1. Has a diagnosis of acute promyelocytic leukemia (M3, APL), accelerated phase or blast crisis of chronic myeloid leukemia. 2. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. 3. Patients with active Central Nervous System (CNS) involvement (such as leukemic infiltration, blast in the spinal fluid, or subjects with extramedullary disease). 4. A WOCBP who has a positive pregnancy test (within 72 hours) prior to treatment. 5. History or evidence of any other clinically significant disorder, condition or disease (e.g., symptomatic congestive heart failure, unstable angina pectoris, symptomatic myocardial infection, uncontrolled cardiac arrhythmia, pericardial disease or heart failure New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity and in the opinion of the Investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures or completion. 6. Chronic respiratory disease or any other medical condition that requires continuous oxygen that in the opinion of the Investigator, would adversely affect his/her participation in this study. 7. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. 8. Is currently participating in or has participated in a study of the following prior to the first dose of study treatment: 1. An investigational biologic or an investigational device within 4 weeks or 5 half-lives (whichever is longer); 2. An investigational oral agent within 2 weeks or 5 half-lives (whichever is shorter). 9. Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior chemotherapy, immunotherapy and radiation therapy) and/or complications from interventions before starting therapy. 10. Has previously had an allogeneic solid organ transplant. 11. Autologous HSCT within 6 weeks before the start of study treatment. 12. Allogeneic HSCT within 6 months before the start of study treatment. 13. Any active acute or chronic graft-versus-host disease (GvHD), grade 2-4, or active chronic GvHD requiring systemic treatment. 14. Any systemic therapy (e.g. calcineurin inhibitors (CNI), steroids, etc.) against GvHD within 4 weeks before the start of study treatment. 15. Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy. 16. Previous CAR-T therapy. 17. Known concurrent malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry after treatment with curative intent. 18. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction to Immunoglobulins or NC525, and/or any of their excipients. 19. Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti-infection treatment at the time of eligibility confirmation. 20. Has a known history of HIV infection. 21. Has a known active chronic hepatitis B infection or chronic hepatitis C infection with the exception of those with an undetectable viral load within 3 months. 22. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate, in the opinion of the treating investigator. 23. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05787496
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NextCure, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Han Myint, MD
Principal Investigator Affiliation NextCure, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Chronic Myelomonocytic Leukemia, Relapsed or Refractory Myelodysplastic Syndrome
Arms & Interventions

Arms

Experimental: NC525

Escalating dose levels will be explored.

Interventions

Drug: - NC525

Monoclonal antibody specific for LAIR-1

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

Samantha Humpal

shumpal@coh.org

626-218-9401

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Alessia Zoso

azoso@miami.edu

(240) 763-0535

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Julie Supanekar

jsupanekar@mgh.harvard.edu

617-724-5253

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

Emma Logan

eklogan@bidmc.harvard.edu

(240) 763-0535

Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine in St. Louis

Saint Louis, Missouri, 63110

Site Contact

Ayan Gasanli

agasanli@wustl.edu

(240) 763-0535

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

Layla Ortiz

Layla.Ortiz@RoswellPark.org

716-845-7559

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10022

Site Contact

Penina Stewart

pes4006@med.cornell.edu

(240) 763-0535

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Site Contact

Sarah Gollwitzer

sarah.gollwitzer@uhhospitals.org

(240) 763-0535

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

India Houston

houstoi3@ccf.org

(240) 763-0535

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Site Contact

Lara Fournier

trials@ohsu.edu

(240) 763-0535

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Danielle Nguyen

dtnguyen7@mdanderson.org

713-792-4133

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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