Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01239368 · OUTCOME

Immune Reconstitution in Recipients of Th1.(T Helper Cell) Rapa Cells.

Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma · Source last updated 2019-12-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Baseline, prior to chemotherapy, and 2 weeks, 1, 2, and 3 months after final T cell infusion

What was measured

Immune reconstitution in recipients of Th1.rapa cells was determined by flow cytometry.

Analysis population: For the planned protocol cohort 7, no pts were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the max. # that could be manufactured due to limiting reagents for cell culture. Outcome measure not done; data not collected in real-time due to premature closure of study.

Groups in this outcome

Cohort 1 - 1x10(5) T Cells/kg

1x10(5) Th1/Tc1.Rapa cells/kg of body weight

Cohort 2 - 5x10(5) T Cells/kg

5x10(5) Th1/Tc1.Rapa cells/kg of body weight

Cohort 3 - 1x10(6) T Cells/kg

1x10(6) Th1/Tc1.Rapa cells/kg of body weight

Cohort 4 - 3x10(6) T Cells/kg

3x10(6) Th1/Tc1.Rapa cells/kg of body weight

Cohort 5 - 5x10(6) T Cells/kg

5x10(6) Th1/Tc1.Rapa cells/kg of body weight

Cohort 5B - 5x10(6) Th1 Rapa Cells/kg

5x10(6) Th1 rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.

Cohort 6 - 15x10(6) T Cells/kg

15x10(6) Th1/Tc1.Rapa cells/kg of body weight

Cohort 7 - 45x10(6) T Cells/kg

45x10(6) Th1/Tc1.Rapa cells/kg of body weight

Cohort A - Th1/Tc1.Rapa Prevention of Relapse

Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg

Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma

Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg

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

Analysis denominator · Participants

GroupSource count
Cohort 1 - 1x10(5) T Cells/kg0
Cohort 2 - 5x10(5) T Cells/kg0
Cohort 3 - 1x10(6) T Cells/kg0
Cohort 4 - 3x10(6) T Cells/kg0
Cohort 5 - 5x10(6) T Cells/kg0
Cohort 5B - 5x10(6) Th1 Rapa Cells/kg0
Cohort 6 - 15x10(6) T Cells/kg0
Cohort 7 - 45x10(6) T Cells/kg0
Cohort A - Th1/Tc1.Rapa Prevention of Relapse0
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma0

Reported measurements

Baseline
Prior to chemotherapy
2 weeks after final T-cell infusion
1 month after final T-cell infusion
2 months after final T-cell infusion
3 months after final T-cell infusion
Complete source fields
classes
  1. title
    Baseline
  2. title
    Prior to chemotherapy
  3. title
    2 weeks after final T-cell infusion
  4. title
    1 month after final T-cell infusion
  5. title
    2 months after final T-cell infusion
  6. title
    3 months after final T-cell infusion
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      0
    units
    Participants
description
Immune reconstitution in recipients of Th1.rapa cells was determined by flow cytometry.
groups
  1. description
    1x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG000
    title
    Cohort 1 - 1x10(5) T Cells/kg
  2. description
    5x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG001
    title
    Cohort 2 - 5x10(5) T Cells/kg
  3. description
    1x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG002
    title
    Cohort 3 - 1x10(6) T Cells/kg
  4. description
    3x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG003
    title
    Cohort 4 - 3x10(6) T Cells/kg
  5. description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG004
    title
    Cohort 5 - 5x10(6) T Cells/kg
  6. description
    5x10(6) Th1 rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
    id
    OG005
    title
    Cohort 5B - 5x10(6) Th1 Rapa Cells/kg
  7. description
    15x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG006
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. description
    45x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG007
    title
    Cohort 7 - 45x10(6) T Cells/kg
  9. description
    Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
    id
    OG008
    title
    Cohort A - Th1/Tc1.Rapa Prevention of Relapse
  10. description
    Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
    id
    OG009
    title
    Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
population Description
For the planned protocol cohort 7, no pts were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the max. # that could be manufactured due to limiting reagents for cell culture. Outcome measure not done; data not collected in real-time due to premature closure of study.
reporting Status
POSTED
time Frame
Baseline, prior to chemotherapy, and 2 weeks, 1, 2, and 3 months after final T cell infusion
title
Immune Reconstitution in Recipients of Th1.(T Helper Cell) Rapa Cells.
type
SECONDARY

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

Preserved source evidence · Not medical advice