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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma, Blood and Marrow Transplant (BMT)

Intervention / Treatment
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* Drug: Cytokine Induced Killer Cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cytokine-induced Killer Cells<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |