Relapsed or Refractory Acute Myeloid LeukemiaPhase 1NCT05787496
A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
A Phase 1 study testing NC525 in people with Relapsed or Refractory Acute Myeloid Leukemia and Relapsed or Refractory Chronic Myelomonocytic Leukemia, run by NextCure, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Chronic Myelomonocytic Leukemia, Relapsed or Refractory Myelodysplastic Syndrome
- What is being tested?
- NC525
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Feb 2023to 31 Jan 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is willing to provide written informed consent for the trial.
- Be ≥ 18 years of age on the day of signing informed consent.
- Subject has one of the following Myeloid Neoplasms determined by pathology review at the treating institution:
- 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,
Show all 18Show fewer
- 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.
- 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.
- Relapsed or Refractory Chronic myelomonocytic leukemia (CMML) with progressive disease or lack of response to hypomethylating agents
- 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.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP);
- 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.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy greater than or equal to 12 weeks as judged by the Investigator.
- Have adequate organ function as defined in the protocol.
Who cannot join
- Has a diagnosis of acute promyelocytic leukemia (M3, APL), accelerated phase or blast crisis of chronic myeloid leukemia.
- 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.
- Patients with active Central Nervous System (CNS) involvement (such as leukemic infiltration, blast in the spinal fluid, or subjects with extramedullary disease).
- A WOCBP who has a positive pregnancy test (within 72 hours) prior to treatment.
- 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.
- 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.
Show all 25Show fewer
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- Is currently participating in or has participated in a study of the following prior to the first dose of study treatment:
- An investigational biologic or an investigational device within 4 weeks or 5 half-lives (whichever is longer);
- An investigational oral agent within 2 weeks or 5 half-lives (whichever is shorter).
- 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.
- Has previously had an allogeneic solid organ transplant.
- Autologous HSCT within 6 weeks before the start of study treatment.
- Allogeneic HSCT within 6 months before the start of study treatment.
- Any active acute or chronic graft-versus-host disease (GvHD), grade 2-4, or active chronic GvHD requiring systemic treatment.
- Any systemic therapy (e.g. calcineurin inhibitors (CNI), steroids, etc.) against GvHD within 4 weeks before the start of study treatment.
- Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.
- Previous CAR-T therapy.
- 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.
- Has severe hypersensitivity (≥ Grade 3), known allergy or reaction to Immunoglobulins or NC525, and/or any of their excipients.
- Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti-infection treatment at the time of eligibility confirmation.
- Has a known history of HIV infection.
- 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.
- 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.
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami
Miami, Florida, 33136
Weill Cornell Medicine
New York, New York, 10022
Oregon Health & Science University
Portland, Oregon, 97239
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Phase 1, Open-Label, Safety, Tolerability, And Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
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.
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Chronic Myelomonocytic Leukemia, Relapsed or Refractory Myelodysplastic Syndrome
- Being tested
- NC525
- Keywords
- Advanced Leukemia, Leukemia, NC525, PK, AML, MDS, CMML
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC525Drug
Monoclonal antibody specific for LAIR-1
| Study group | Role | What they receive |
|---|---|---|
| 2mg/kg NC525 | Experimental | Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. Receives: Drug: NC525 |
| 2.5mg/kg NC525 | Experimental | Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. Receives: Drug: NC525 |
| 4.5mg/kg NC525 | Experimental | Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Receives: Drug: NC525 |
| 9mg/kg NC525 | Experimental | Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Receives: Drug: NC525 |
| 13.5mg/kg NC525 | Experimental | Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Receives: Drug: NC525 |
| 18mg/kg NC525 | Experimental | Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Receives: Drug: NC525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].
Toxicity grading per NCI CTCAE v5.0.
Measured: Up to 23 months
To Evaluate Dose-limiting Toxicities (DLTs) of NC525.
Toxicity grading per NCI CTCAE v5.0.
Measured: Up to 56 days
Secondary outcomes (7)
To Evaluate the Clinical Benefit of NC525 by Assessing Objective Response (OR).
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Measured: Until disease progression, up to 23 months
To Evaluate the Clinical Benefit of NC525 by Assessing Event-free Survival (EFS).
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Measured: Until disease progression, up to 23 months
To Evaluate the Clinical Benefit of NC525 by Assessing Overall Survival (OS).
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Measured: Time until death, up to 23 months
Assessment of Time to Achieve Response, Defined as CR, CRi, or CRh
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Measured: Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days)
Maximum Observed Serum Concentration (Cmax) of NC525
To evaluate the maximum observed serum concentration (Cmax) of NC525. The values reported are Cmax at Cycle 2 Day 1.
Measured: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days)
Terminal Half-life (t1/2) of NC525
To evaluate the Terminal Half-life (t1/2) of NC525.
Measured: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported
Area Under the Serum Concentration Versus Time Curve (AUC) of NC525
To evaluate area under the serum concentration versus time curve (AUC) of NC525
Measured: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start28 Feb 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: As a result of program reprioritization and due to the limited clinical activity observed in the Phase 1 trial, the study has been discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed or Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han Myint, MD, Study director, NextCure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787496
- Sponsor's protocol ID
- NC525-01
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2023
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Safety, Tolerability, And Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
- ClinicalTrials.gov ID
- NCT05787496
- Acronym / sponsor ID
- NC525-01
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Chronic Myelomonocytic Leukemia, Relapsed or Refractory Myelodysplastic Syndrome
- Keywords
- Advanced Leukemia, Leukemia, NC525, PK, AML, MDS, CMML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As a result of program reprioritization and due to the limited clinical activity observed in the Phase 1 trial, the study has been discontinued.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NextCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 2mg/kg NC525 | Experimental | Drug: NC525Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. |
| 2.5mg/kg NC525 | Experimental | Drug: NC525Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. |
| 4.5mg/kg NC525 | Experimental | Drug: NC525Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. |
| 9mg/kg NC525 | Experimental | Drug: NC525Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. |
| 13.5mg/kg NC525 | Experimental | Drug: NC525Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. |
| 18mg/kg NC525 | Experimental | Drug: NC525Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The subject is willing to provide written informed consent for the trial.
- Be ≥ 18 years of age on the day of signing informed consent.
- Subject has one of the following Myeloid Neoplasms determined by pathology review at the treating institution:
- Note: Subject must have sub-type MDS-EB2 with 10-19% blasts by bone marrow biopsy or aspirate.
- 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.
Key exclusion criteria (25 listed)
- Has a diagnosis of acute promyelocytic leukemia (M3, APL), accelerated phase or blast crisis of chronic myeloid leukemia.
- 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.
- Patients with active Central Nervous System (CNS) involvement (such as leukemic infiltration, blast in the spinal fluid, or subjects with extramedullary disease).
- A WOCBP who has a positive pregnancy test (within 72 hours) prior to treatment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NC525Monoclonal antibody specific for LAIR-1 | Drug | 13.5mg/kg NC525, 18mg/kg NC525, 2.5mg/kg NC525, 2mg/kg NC525, 4.5mg/kg NC525, 9mg/kg NC525 |
Primary outcome
To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].
Time frame: Up to 23 months
Toxicity grading per NCI CTCAE v5.0.
To Evaluate Dose-limiting Toxicities (DLTs) of NC525.
Time frame: Up to 56 days
Toxicity grading per NCI CTCAE v5.0.
7 secondary outcomes
To Evaluate the Clinical Benefit of NC525 by Assessing Objective Response (OR).
Time frame: Until disease progression, up to 23 months
To Evaluate the Clinical Benefit of NC525 by Assessing Event-free Survival (EFS).
Time frame: Until disease progression, up to 23 months
To Evaluate the Clinical Benefit of NC525 by Assessing Overall Survival (OS).
Time frame: Time until death, up to 23 months
Assessment of Time to Achieve Response, Defined as CR, CRi, or CRh
Time frame: Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days)
Maximum Observed Serum Concentration (Cmax) of NC525
Time frame: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days)
Terminal Half-life (t1/2) of NC525
Time frame: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported
Area Under the Serum Concentration Versus Time Curve (AUC) of NC525
Time frame: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Myint, MD study director
NextCure, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NC525 in people with Relapsed or Refractory Acute Myeloid Leukemia and Relapsed or Refractory Chronic Myelomonocytic Leukemia, run by NextCure, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability]. (time frame: Up to 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.