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NCT03568461 · OUTCOME

Humoral Immunogenicity: Number of Participants With Anti-mCAR19 Antibodies, Per IRC Assessment

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma · Source last updated 2026-07-09

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
at any time post-baseline, up to 24 months post-infusion

What was measured

Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion. Percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline. A participant was only defined as positive for tisagenlecleucel treatment-induced or -boosted anti-mCAR19 antibodies when the anti-mCAR19 antibody median fluorescence intensity (MFI) at any time post-infusion was at least 2.28-fold higher than pre-infusion levels for patients whose baseline status was positive (boosted) or if the baseline status was negative, but any post-baseline interpretation was positive (induced).

Analysis population: Safety Set: The Safety set comprised of all participants who received tisagenlecleucel.

Groups in this outcome

CTL019

All participants who were enrolled in the study

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

Analysis denominator · Participants

GroupSource count
CTL01997

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CTL01991Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        91
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    units
    Participants
description
Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion. Percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline. A participant was only defined as positive for tisagenlecleucel treatment-induced or -boosted anti-mCAR19 antibodies when the anti-mCAR19 antibody median fluorescence intensity (MFI) at any time post-infusion was at least 2.28-fold higher than pre-infusion levels for patients whose baseline status was positive (boosted) or if the baseline status was negative, but any post-baseline interpretation was positive (induced).
groups
  1. description
    All participants who were enrolled in the study
    id
    OG000
    title
    CTL019
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Set: The Safety set comprised of all participants who received tisagenlecleucel.
reporting Status
POSTED
time Frame
at any time post-baseline, up to 24 months post-infusion
title
Humoral Immunogenicity: Number of Participants With Anti-mCAR19 Antibodies, Per IRC Assessment
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice