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

NCT00185757 | Unknown Phase 1

• 4 other identifiers: BMT16295070NCT0018575713644
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Blood and Marrow Transplant (BMT)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (1)

Cytokine-induced Killer Cells

EXPERIMENTAL

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

Interventions

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

Cytokine-induced Killer Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eligible for DLI
• no evidence of GVHD
• stable immunosuppressive regimen

Sponsors & Collaborators

• Robert Negrin: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robert S Negrin

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)