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NCT04824794 · OUTCOME

Expansion Part B: Number of Participants With Anti-GEN3014 Antibodies and Anti-Daratumumab Antibodies

GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies · Source last updated 2026-05-19

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
Cycle 1 Day 22 up to a maximum of approximately 23.9 months (cycles = 28 days)

What was measured

Venous blood samples were drawn for analysis of ADAs to GEN3014 and daratumumab. In the GEN3014 arm, participants were tested for anti-GEN3014-antibodies; in the daratumumab arm, participants were tested for anti-daratumumab-antibodies.

Analysis population: The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of trial drug and had baseline ADA, and at least 1 evaluable on-treatment ADA sample. Overall number of participants analysed = participants evaluable for the OM.

Groups in this outcome

RRMM Expansion Part B: Daratumumab

Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.

RRMM Expansion Part B: GEN3014

Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.

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

Analysis denominator · Participants

GroupSource count
RRMM Expansion Part B: Daratumumab41
RRMM Expansion Part B: GEN301441

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RRMM Expansion Part B: Daratumumab0Not reportedNot reportedNot reportedNot reported
RRMM Expansion Part B: GEN30142Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      41
    units
    Participants
description
Venous blood samples were drawn for analysis of ADAs to GEN3014 and daratumumab. In the GEN3014 arm, participants were tested for anti-GEN3014-antibodies; in the daratumumab arm, participants were tested for anti-daratumumab-antibodies.
groups
  1. description
    Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
    id
    OG000
    title
    RRMM Expansion Part B: Daratumumab
  2. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
    id
    OG001
    title
    RRMM Expansion Part B: GEN3014
param Type
COUNT_OF_PARTICIPANTS
population Description
The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of trial drug and had baseline ADA, and at least 1 evaluable on-treatment ADA sample. Overall number of participants analysed = participants evaluable for the OM.
reporting Status
POSTED
time Frame
Cycle 1 Day 22 up to a maximum of approximately 23.9 months (cycles = 28 days)
title
Expansion Part B: Number of Participants With Anti-GEN3014 Antibodies and Anti-Daratumumab Antibodies
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice