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NCT06055075 · OUTCOME

Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-09-29

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
From initiation of study treatment up to approximately 15.7 months

What was measured

ICANS grade is determined by the most severe event (immune effector cell-associated encephalopathy \[ICE\] score, level of consciousness, seizures, motor findings, raised intracranial pressure \[ICP\]/cerebral edema) not attributed to any other cause. Grade 1=ICE score of 7-9; awakens spontaneously; no seizure/motor findings/elevated ICP/cerebral edema. Grade 2=ICE score of 3-6; awakes voice; no seizure/motor findings/elevated ICP/cerebral edema. Grade 3=ICE score of 0-2; awakes only to tactile stimulus; any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizure on EEG that resolves with intervention; no motor findings; focal/local edema on neuroimaging.

Analysis population: Safety population included all participants enrolled in the study who received any amount of any study treatment.

Groups in this outcome

Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib

Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).

Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib

Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).

Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib

Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).

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

Analysis denominator · Participants

GroupSource count
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib7
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib6
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib6

Reported measurements

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib3Not reportedNot reportedNot reportedNot reported
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib1Not reportedNot reportedNot reportedNot reported
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib2Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib0Not reportedNot reportedNot reportedNot reported
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib1Not reportedNot reportedNot reportedNot reported
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib1Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib1Not reportedNot reportedNot reportedNot reported
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib0Not reportedNot reportedNot reportedNot reported
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
ICANS grade is determined by the most severe event (immune effector cell-associated encephalopathy \[ICE\] score, level of consciousness, seizures, motor findings, raised intracranial pressure \[ICP\]/cerebral edema) not attributed to any other cause. Grade 1=ICE score of 7-9; awakens spontaneously; no seizure/motor findings/elevated ICP/cerebral edema. Grade 2=ICE score of 3-6; awakes voice; no seizure/motor findings/elevated ICP/cerebral edema. Grade 3=ICE score of 0-2; awakes only to tactile stimulus; any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizure on EEG that resolves with intervention; no motor findings; focal/local edema on neuroimaging.
groups
  1. description
    Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    OG000
    title
    Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib
  2. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    OG001
    title
    Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib
  3. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    OG002
    title
    Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants enrolled in the study who received any amount of any study treatment.
reporting Status
POSTED
time Frame
From initiation of study treatment up to approximately 15.7 months
title
Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice