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NCT03568461 · OUTCOME

Cellular Immunogenicity: Percentage of Interferon Gamma (IFNg+) Cells by Flow Cytometry 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
MEDIAN
Unit
% of interferon gamma (IFNg+) cells
Interval / dispersion
Full Range
Time frame
pre-infusion (pre-Lymph depletion evaluation), 24 months post-infusion

What was measured

Activation of T-cells in peripheral blood mononuclear cells collected from participants in response to mCAR19-derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. T-cell activation was measured by the percentage of interferon gamma (IFNg+) cells by flow cytometry. Cellular responses to mCART peptides were measured pre-infusion (enrollment) and post-tisagenlecleucel infusion. Pool 1 and Pool 2 are a pool of 60 peptides (peptides 1-60) and 59 peptides (peptides 61-119) , respectively, corresponding to the CTL019 transgene product. Together, they comprised 119 peptides spanning the CTL019 transgene product and were used to stimulate PBMCs to detect antigen-specific T cell responses via intracellular cytokine staining.

Analysis population: Efficacy analysis set (EAS) comprised of all patients who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).

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
CTL01994

Reported measurements

Baseline: CTL019 Pool 1 CD3+ CD4+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01981
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190.001Not reported00.302Not reported
Month 24: CTL019 Pool 1 CD3+ CD4+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01959
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190.00346Not reported00.110Not reported
Baseline: CTL019 Pool 2 CD3+ CD4+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01981
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190Not reported00.320Not reported
Month 24: CTL019 Pool 2 CD3+ CD4+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01959
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190.00275Not reported00.140Not reported
Baseline: CTL019 Pool 1 CD3+ CD8+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01981
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190Not reported02.38Not reported
Month 24: CTL019 Pool 1 CD3+ CD8+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01959
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190.001Not reported00.144Not reported
Baseline: CTL019 Pool 2 CD3+ CD8+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01981
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190Not reported00.350Not reported
Month 24: CTL019 Pool 2 CD3+ CD8+ IFNg+

Analysis denominator · Participants

GroupSource count
CTL01959
Values in % of interferon gamma (IFNg+) cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CTL0190Not reported00.520Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.302
        value
        0.001
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Baseline: CTL019 Pool 1 CD3+ CD4+ IFNg+
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.110
        value
        0.00346
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Month 24: CTL019 Pool 1 CD3+ CD4+ IFNg+
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.320
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Baseline: CTL019 Pool 2 CD3+ CD4+ IFNg+
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.140
        value
        0.00275
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Month 24: CTL019 Pool 2 CD3+ CD4+ IFNg+
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2.38
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Baseline: CTL019 Pool 1 CD3+ CD8+ IFNg+
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.144
        value
        0.001
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Month 24: CTL019 Pool 1 CD3+ CD8+ IFNg+
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.350
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Baseline: CTL019 Pool 2 CD3+ CD8+ IFNg+
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.520
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Month 24: CTL019 Pool 2 CD3+ CD8+ IFNg+
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    units
    Participants
description
Activation of T-cells in peripheral blood mononuclear cells collected from participants in response to mCAR19-derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. T-cell activation was measured by the percentage of interferon gamma (IFNg+) cells by flow cytometry. Cellular responses to mCART peptides were measured pre-infusion (enrollment) and post-tisagenlecleucel infusion. Pool 1 and Pool 2 are a pool of 60 peptides (peptides 1-60) and 59 peptides (peptides 61-119) , respectively, corresponding to the CTL019 transgene product. Together, they comprised 119 peptides spanning the CTL019 transgene product and were used to stimulate PBMCs to detect antigen-specific T cell responses via intracellular cytokine staining.
dispersion Type
Full Range
groups
  1. description
    All participants who were enrolled in the study
    id
    OG000
    title
    CTL019
param Type
MEDIAN
population Description
Efficacy analysis set (EAS) comprised of all patients who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).
reporting Status
POSTED
time Frame
pre-infusion (pre-Lymph depletion evaluation), 24 months post-infusion
title
Cellular Immunogenicity: Percentage of Interferon Gamma (IFNg+) Cells by Flow Cytometry Per IRC Assessment
type
SECONDARY
unit Of Measure
% of interferon gamma (IFNg+) cells

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

Preserved source evidence · Not medical advice