Skip to main content
OpenTrials
Completed

NCT Number: NCT00185757

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

This is a phase 1 dose escalation study evaluating the use of activated T-cells to treat relapsed malignancy (cancer) following allogeneic hematopoietic cell transplantation, without causing GvHD.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Blood and Marrow Transplant (BMT) Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

This study did not advance to dose expansion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytokine Induced Killer Cells

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.

    Time frame: first 100 days after infusion

  4. To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.

    Time frame: day plus 100 after infusion

Secondary outcomes

  1. o determine the incidence of disease response following treatment with allogeneic CIK cells.

    Time frame: one year

  2. To assess donor-specific chimerism before and after treatment with allogeneic CIK cells.

    Time frame: 3 months

  3. To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system.

    Time frame: 21-28 days

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2005
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.