Trial Title:
A Safety, Tolerability and Efficacy Study of NC525 in Subjects with Advanced Myeloid Neoplasms
NCT ID:
NCT05787496
Condition:
Relapsed or Refractory Acute Myeloid Leukemia
Relapsed or Refractory Chronic Myelomonocytic Leukemia
Relapsed or Refractory Myelodysplastic Syndrome
Conditions: Official terms:
Leukemia
Neoplasms
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Conditions: Keywords:
Advanced Leukemia
Leukemia
NC525
PK
AML
MDS
CMML
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NC525
Description:
Monoclonal antibody specific for LAIR-1
Arm group label:
NC525
Summary:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Washington University School of Medicine in St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Facility:
Name:
Weill Cornell Medicine
Address:
City:
New York
Zip:
10022
Country:
United States
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
February 28, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
NextCure, Inc.
Agency class:
Industry
Source:
NextCure, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787496
