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NCT05787496 · OUTCOME

Assessment of Time to Achieve Response, Defined as CR, CRi, or CRh

A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms · Source last updated 2026-01-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days)

What was measured

Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.

Analysis population: 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

Groups in this outcome

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

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

4.5mg/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

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

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

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
2mg/kg NC5253
2.5mg/kg NC5254
4.5mg/kg NC5253
9mg/kg NC52511
13.5mg/kg NC5254
18mg/kg NC5253

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
2mg/kg NC525NANot reportedNANAInsufficient number of participants with events.
2.5mg/kg NC525NANot reportedNANAInsufficient number of participants with events.
4.5mg/kg NC525NANot reportedNANAInsufficient number of participants with events.
9mg/kg NC525NANot reported1.8NAInsufficient number of participants with events.
13.5mg/kg NC525NANot reportedNANAInsufficient number of participants with events.
18mg/kg NC525NANot reportedNANAInsufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Insufficient number of participants with events.
        group Id
        OG003
        lower Limit
        1.8
        upper Limit
        NA
        value
        NA
      5. comment
        Insufficient number of participants with events.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. comment
        Insufficient number of participants with events.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      3
    units
    Participants
description
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
dispersion Type
95% Confidence Interval
groups
  1. description
    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
    id
    OG000
    title
    2mg/kg NC525
  2. description
    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
    id
    OG001
    title
    2.5mg/kg NC525
  3. description
    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
    id
    OG002
    title
    4.5mg/kg NC525
  4. description
    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
    id
    OG003
    title
    9mg/kg NC525
  5. description
    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
    id
    OG004
    title
    13.5mg/kg NC525
  6. description
    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
    id
    OG005
    title
    18mg/kg NC525
param Type
MEDIAN
population Description
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
reporting Status
POSTED
time Frame
Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days)
title
Assessment of Time to Achieve Response, Defined as CR, CRi, or CRh
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice