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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.