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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00185757
• Other study ID #: BMT162
• Secondary ID: 95070BMT16213644
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: December 13, 2012
• Start date: June 2004
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood and Marrow Transplant (BMT)
• Multiple Myeloma

Intervention

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 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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Robert Negrin	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.		first 100 days after infusion	Yes
Primary	To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.		day plus 100 after infusion	Yes
Secondary	o determine the incidence of disease response following treatment with allogeneic CIK cells.		one year	No
Secondary	To assess donor-specific chimerism before and after treatment with allogeneic CIK cells.		3 months	No
Secondary	To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system.		21-28 days	No