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As a result of program reprioritization and due to the limited clinical activity observed in the Phase 1 trial, the study has been discontinued.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NC525 | Drug | Monoclonal antibody specific for LAIR-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability]. | Toxicity grading per NCI CTCAE v5.0. | Up to 23 months |
| To Evaluate Dose-limiting Toxicities (DLTs) of NC525. | Toxicity grading per NCI CTCAE v5.0. | Up to 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until disease progression, up to 23 months |
| To Evaluate the Clinical Benefit of NC525 by Assessing Event-free Survival (EFS). |
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Inclusion Criteria:
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:
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:
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.
Exclusion Criteria:
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.
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Han Myint, MD | NextCure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of Miami |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2mg/kg NC525 | Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1 |
| FG001 | 2.5mg/kg NC525 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2023 |
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|
| 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. |
|
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures. |
| 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. | 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. | 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. | 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. | 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 | During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported |
| Miami |
| Florida |
| 33136 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Cornell Medicine | New York | New York | 10022 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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.
NC525: Monoclonal antibody specific for LAIR-1
| FG002 | 4.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| FG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| FG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| FG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2mg/kg NC525 | Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1 |
| BG001 | 2.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| BG002 | 4.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| BG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| BG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| BG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability]. | Toxicity grading per NCI CTCAE v5.0. | Safety Analysis Set (SAS): The SAS will include all the subjects who receive any amount of NC525 and will be used for summaries and analyses of safety data. | Posted | Count of Participants | Participants | Up to 23 months |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | To Evaluate Dose-limiting Toxicities (DLTs) of NC525. | Toxicity grading per NCI CTCAE v5.0. | Safety Analysis Set (SAS): The SAS will include all the subjects who receive any amount of NC525 and will be used for summaries and analyses of safety data | Posted | Count of Participants | Participants | Up to 56 days |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK | Posted | Count of Participants | Participants | Until disease progression, up to 23 months |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK | Posted | Median | 95% Confidence Interval | months | Until disease progression, up to 23 months |
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| Secondary | 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. | Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK. The analysis population includes all participants who received at least one dose of NC525 in each dose cohort. All participants were included in the analysis regardless of whether they experienced the event (death). Overall survival was analyzed using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | Time until death, up to 23 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. | Posted | Mean | Standard Deviation | μg/mL | During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Half-life (t1/2) of NC525 | To evaluate the Terminal Half-life (t1/2) of NC525. | The PK analysis set includes participants who received NC525 and had sufficient concentration-time data to estimate terminal half-life (t1/2) using noncompartmental analysis. Estimation required an identifiable terminal elimination phase with ≥3 quantifiable post-dose samples. Descriptive statistics were calculated when ≥3 participants had an estimable t1/2. When only 1 participant had an estimable value, the mean is reported and the standard deviation is not calculable. | Posted | Mean | Standard Deviation | h | During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration Versus Time Curve (AUC) of NC525 | To evaluate area under the serum concentration versus time curve (AUC) of NC525 | The PK analysis set includes participants who received NC525 and had sufficient concentration-time data to estimate AUC using noncompartmental analysis for Cycle 1 Day 1. Participants without adequate quantifiable PK samples were excluded for this parameter. Descriptive statistics were calculated when multiple participants had estimable AUC values. When only one participant had an estimable value, the mean is reported and the standard deviation is not calculable. | Posted | Mean | Standard Deviation | h*μg/mL | During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported |
|
From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2mg/kg NC525 | Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1 | 3 | 3 | 3 | 3 | 3 | 3 |
| EG001 | 2.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 | 4 | 4 | 2 | 4 | 4 | 4 |
| EG002 | 4.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 | 3 | 3 | 2 | 3 | 3 | 3 |
| EG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 | 9 | 11 | 9 | 11 | 11 | 11 |
| EG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 | 2 | 4 | 4 | 4 | 4 | 4 |
| EG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 | 2 | 3 | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Differentiation syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vascular access site swelling | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood uric acid decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myalgia intercostal | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Differentiation syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
PI cannot publish study results before the first multi-center publication. If a multi-center publication is not submitted within 12 months after the end of the study at all sites, or if Sponsor confirms there will be no multi-center publication, the PI may publish study results. However, PI will allow Sponsor at least 30 days to review any publication of study results and Sponsor may request an additional 60 days to review the publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | NextCure, Inc | 240-399-4900 | NCClin@nextcure.com |
| Nov 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015470 | Leukemia, Myeloid, Acute |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D009190 | Myelodysplastic Syndromes |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 |
| 9mg/kg NC525 |
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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|
| OG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|
| OG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|
| 4.5mg/kg NC525 |
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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|
| OG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|
| OG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|
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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|
| 4.5mg/kg NC525 |
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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG003 | 9mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG004 | 13.5mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
| OG005 | 18mg/kg NC525 | 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. NC525: Monoclonal antibody specific for LAIR-1 |
|
|