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NCT02408016 · OUTCOME

Persistence of Transduced T Cells

Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma · Source last updated 2021-09-13

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 100 days after the last T cell infusion

What was measured

In vivo persistence of cells generated from the TN subset with cells generated from the TCM subset will be directly compared within each patient by high throughput T-cell receptor (TCR) beta sequencing. The one-sample T test will be used to assess the difference in mean persistence between groups, in which the outcome for each patient is the time to disappearance of infused cytotoxic T lymphocytes.

Analysis population: No patients were treated in Arm II

Groups in this outcome

Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)

Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies

Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)

Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies

Arm II (T Lymphocytes, IL-2, Surgery)

Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection

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

Analysis denominator · Participants

GroupSource count
Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)6
Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)4
Arm II (T Lymphocytes, IL-2, Surgery)0

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)NANot reportedNot reportedNot reportedThis outcome could not be assessed. Although we detected persistence if T cells by tetramer staining in all patients, the transduced cells came from the endogenous repertoire from each patient. As the pre-T cell infusion leaves were elevated, we could not detect changes in TN vs TCM using high-throughput TCR sequencing.
Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)NANot reportedNot reportedNot reportedThis outcome could not be assessed. Although we detected persistence if T cells by tetramer staining in all patients, the transduced cells came from the endogenous repertoire from each patient. As the pre-T cell infusion leaves were elevated, we could not detect changes in TN vs TCM using high-throughput TCR sequencing.
Arm II (T Lymphocytes, IL-2, Surgery)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        This outcome could not be assessed. Although we detected persistence if T cells by tetramer staining in all patients, the transduced cells came from the endogenous repertoire from each patient. As the pre-T cell infusion leaves were elevated, we could not detect changes in TN vs TCM using high-throughput TCR sequencing.
        group Id
        OG000
        value
        NA
      2. comment
        This outcome could not be assessed. Although we detected persistence if T cells by tetramer staining in all patients, the transduced cells came from the endogenous repertoire from each patient. As the pre-T cell infusion leaves were elevated, we could not detect changes in TN vs TCM using high-throughput TCR sequencing.
        group Id
        OG001
        value
        NA
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      0
    units
    Participants
description
In vivo persistence of cells generated from the TN subset with cells generated from the TCM subset will be directly compared within each patient by high throughput T-cell receptor (TCR) beta sequencing. The one-sample T test will be used to assess the difference in mean persistence between groups, in which the outcome for each patient is the time to disappearance of infused cytotoxic T lymphocytes.
groups
  1. description
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
  2. description
    Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG001
    title
    Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
  3. description
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection
    id
    OG002
    title
    Arm II (T Lymphocytes, IL-2, Surgery)
param Type
COUNT_OF_PARTICIPANTS
population Description
No patients were treated in Arm II
reporting Status
POSTED
time Frame
Up to 100 days after the last T cell infusion
title
Persistence of Transduced T Cells
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice