Back to resultsCytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation
Primary Purpose
Multiple Myeloma, Blood and Marrow Transplant (BMT)
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cytokine Induced Killer Cells
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:- Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant eligible for DLI no evidence of GVHD stable immunosuppressive regimen adequate renal and liver function Exclusion Criteria:- CML patients who have not received DLI, active infections
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cytokine-induced Killer Cells
Arm Description
The first cohort =1X10 7 cf expanded cells/kg. The second cohort = 5x10 7 expanded cells/kg. The second cohort = 1X10 8 expanded cells/kg.
Outcomes
Primary Outcome Measures
To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system.
To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation.
To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.
To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.
Secondary Outcome Measures
o determine the incidence of disease response following treatment with allogeneic CIK cells.
To assess donor-specific chimerism before and after treatment with allogeneic CIK cells.
To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system.
Full Information
NCT ID
NCT00185757
First Posted
September 12, 2005
Last Updated
December 13, 2012
Sponsor
Robert Negrin
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00185757
Brief Title
Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation
Official Title
Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Negrin
Collaborators
National Institutes of Health (NIH)
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine if the use of activated T cells can effectively treat relapsed disease following allogeneic hematopoietic cell transplantation without causing GVHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Blood and Marrow Transplant (BMT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cytokine-induced Killer Cells
Arm Type
Experimental
Arm Description
The first cohort =1X10 7 cf expanded cells/kg. The second cohort = 5x10 7 expanded cells/kg. The second cohort = 1X10 8 expanded cells/kg.
Intervention Type
Drug
Intervention Name(s)
Cytokine Induced Killer Cells
Intervention Description
CIK cell dose escalation will be performed in cohorts of three patients per group. The initial dose utilized will be 1x107 expanded cells/kg. Previously, unmanipulated donor lymphocytes administered at this dose did not result in significant GVHD 7. The expansion of the CIK cell population is expected to diminish the T cell subsets responsible for GVHD further reducing the risk of GVHD to recipients. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients
Primary Outcome Measure Information:
Title
To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system.
Time Frame
21 to 28days before infusion
Title
To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation.
Time Frame
day of infusion up to 24 hours after infusion
Title
To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.
Time Frame
first 100 days after infusion
Title
To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.
Time Frame
day plus 100 after infusion
Secondary Outcome Measure Information:
Title
o determine the incidence of disease response following treatment with allogeneic CIK cells.
Time Frame
one year
Title
To assess donor-specific chimerism before and after treatment with allogeneic CIK cells.
Time Frame
3 months
Title
To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system.
Time Frame
21-28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant
eligible for DLI
no evidence of GVHD
stable immunosuppressive regimen
adequate renal and liver function Exclusion Criteria:- CML patients who have not received DLI, active infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Negrin
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation
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