Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

Sponsor

Robert Negrin (Other)

Overall Status

Unknown status

CT.gov ID

NCT00185757

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arm

102

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Blood and Marrow Transplant (BMT)	Drug: Cytokine Induced Killer Cells	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

Study Start Date :

Jun 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cytokine-induced Killer Cells 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.	Drug: Cytokine Induced Killer Cells 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

Arm

Intervention/Treatment

Experimental: Cytokine-induced Killer Cells

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.

Drug: Cytokine Induced Killer Cells

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

Outcome Measures

Primary Outcome Measures

To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system. [21 to 28days before infusion]
To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation. [day of infusion up to 24 hours after infusion]
To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells. [first 100 days after infusion]
To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion. [day plus 100 after infusion]

Secondary Outcome Measures

o determine the incidence of disease response following treatment with allogeneic CIK cells. [one year]
To assess donor-specific chimerism before and after treatment with allogeneic CIK cells. [3 months]
To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system. [21-28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

Robert Negrin
National Institutes of Health (NIH)

Investigators

Principal Investigator: Robert S Negrin, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Negrin, Professor of Medicine, Stanford University

ClinicalTrials.gov Identifier:

NCT00185757

Other Study ID Numbers:

BMT162
95070
BMT162
13644

First Posted:

Sep 16, 2005

Last Update Posted:

Dec 17, 2012

Last Verified:

Dec 1, 2012

Additional relevant MeSH terms:

Multiple Myeloma

Study Results

No Results Posted as of Dec 17, 2012