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

Phase 1

• Conditions: Blood and Marrow Transplant (BMT); Multiple Myeloma
• Interventions: Drug: Cytokine Induced Killer Cells

• Registration Number: NCT00185757
• Lead Sponsor: Robert Negrin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytokine-induced Killer Cells	Cytokine Induced Killer Cells	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
o determine the incidence of disease response following treatment with allogeneic CIK cells.	one year

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States