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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Interventions

  • 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 1×107 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 5×107 expanded cells/kg and 1×108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients

Arms, Groups and Cohorts

  • Experimental: Cytokine-induced Killer Cells
    • The first cohort =1X10 7 cf expanded cells/kg. The second cohort = 5×10 7 expanded cells/kg. The second cohort = 1X10 8 expanded cells/kg.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Robert Negrin
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Robert Negrin, Professor of Medicine – Stanford University
  • Overall Official(s)
    • Robert S Negrin, Principal Investigator, Stanford University

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