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

Robert Negrin20 enrolled

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma Blood and Marrow Transplant (BMT)

Interventions

Cytokine Induced Killer CellsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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