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NCT00439465 · OUTCOME

Determine the Methods of Tumor Cell Killing of the in Vivo CD8+ Cells: Cytotoxicity Assays, Blocking Experiments, Analysis of T-cell Receptor (TCR)

Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma · Source last updated 2019-03-26

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
Pre-transplant and following the third and fourth cellular infusions.

What was measured

We will isolate the CD8+ populations (CD3+CD8+, CD8+CD56+) using the Auto MACS (Miltenyi) and then identify the mechanisms of tumor cell killing by the CD8+ cells obtained pre-transplant (Baseline) and following the third and fourth cellular infusions. We will examine mechanisms of tumor cell killing through NKG2D receptor, major histocompatibility complex (MHC) Class I molecules or through the T cell receptor. We postulate the CD8+ cells obtained from patient's blood will kill tumor cells both via MHC Class I and through the NKG2D receptor.

Analysis population: Autologous myeloma cells were isolated for only 4 study participants. There is no information on the remaining participant provided.

Groups in this outcome

Ex-vivo Expanded Effector Cells

Infusing Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF)post-Hematopoietic stem cell transplant (HSCT) Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.

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

Analysis denominator · Participants

GroupSource count
Ex-vivo Expanded Effector Cells5

Reported measurements

Autologous Myeloma Cells

Analysis denominator · Participants

GroupSource count
Ex-vivo Expanded Effector Cells4

Increased tumor lysis

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ex-vivo Expanded Effector Cells4Not reportedNot reportedNot reportedNot reported

Failure of tumor lysis

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ex-vivo Expanded Effector Cells0Not reportedNot reportedNot reportedNot reported
Peripheral blood mononuclear cells

Analysis denominator · Participants

GroupSource count
Ex-vivo Expanded Effector Cells5

Increased tumor lysis

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ex-vivo Expanded Effector Cells5Not reportedNot reportedNot reportedNot reported

Failure of tumor lysis

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ex-vivo Expanded Effector Cells0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      Increased tumor lysis
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Failure of tumor lysis
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Autologous Myeloma Cells
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      title
      Increased tumor lysis
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Failure of tumor lysis
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Peripheral blood mononuclear cells
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
We will isolate the CD8+ populations (CD3+CD8+, CD8+CD56+) using the Auto MACS (Miltenyi) and then identify the mechanisms of tumor cell killing by the CD8+ cells obtained pre-transplant (Baseline) and following the third and fourth cellular infusions. We will examine mechanisms of tumor cell killing through NKG2D receptor, major histocompatibility complex (MHC) Class I molecules or through the T cell receptor. We postulate the CD8+ cells obtained from patient's blood will kill tumor cells both via MHC Class I and through the NKG2D receptor.
groups
  1. description
    Infusing Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF)post-Hematopoietic stem cell transplant (HSCT) Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
    id
    OG000
    title
    Ex-vivo Expanded Effector Cells
param Type
COUNT_OF_PARTICIPANTS
population Description
Autologous myeloma cells were isolated for only 4 study participants. There is no information on the remaining participant provided.
reporting Status
POSTED
time Frame
Pre-transplant and following the third and fourth cellular infusions.
title
Determine the Methods of Tumor Cell Killing of the in Vivo CD8+ Cells: Cytotoxicity Assays, Blocking Experiments, Analysis of T-cell Receptor (TCR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice