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NCT05787496 · OUTCOME

To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 23 months

What was measured

Toxicity grading per NCI CTCAE v5.0.

Analysis population: 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.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
2mg/kg NC5253Not reportedNot reportedNot reportedNot reported
2.5mg/kg NC5254Not reportedNot reportedNot reportedNot reported
4.5mg/kg NC5253Not reportedNot reportedNot reportedNot reported
9mg/kg NC52511Not reportedNot reportedNot reportedNot reported
13.5mg/kg NC5254Not reportedNot reportedNot reportedNot reported
18mg/kg NC5253Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
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
Toxicity grading per NCI CTCAE v5.0.
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
COUNT_OF_PARTICIPANTS
population Description
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.
reporting Status
POSTED
time Frame
Up to 23 months
title
To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice