Overview

This trial is active, not recruiting.

Conditions multiple myeloma, blood and marrow transplant (bmt)
Treatment cytokine induced killer cells
Phase phase 1
Sponsor Robert Negrin
Collaborator National Institutes of Health (NIH)
Start date June 2004
End date December 2012
Trial size 20 participants
Trial identifier NCT00185757, 13644, 95070, BMT162

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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

Primary Outcomes

Measure
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
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
To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.
time frame: first 100 days after infusion
To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.
time frame: day plus 100 after infusion

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation
Principal investigator Robert S Negrin
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Stanford University.