CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease (CMV-BMT)

November 8, 2012 updated by: H. Kim Lyerly

A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease

The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this clinical trial is to evaluate the safety of this treatment.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy
  • Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
  • Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
  • Donor must be CMV sero-positive.
  • Karnofsky performance status ≥ 70%.
  • Subject and donor must be one of the following HLA types: HLA A*0201, HLA-A*0101, HLA-A*2402, HLA-B*0702, HLA-B*0801, HLA-B*35, HLA-DR*1, or HLA-DR*4.
  • Availability of the stem cell donor to provide multiple PBMC samples for T-cell culture if needed. These samples could be obtained via a 90cc peripheral blood draw or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis if this is necessary.
  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
  • Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
  • In order to receive their T cell infusions, subjects should be:
  • At least 2 weeks from the time of their allogeneic stem cell transplant.
  • Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1 week; all non major organ toxicities must have resolved to grade-2 or less.

Exclusion Criteria:

  • Pregnant women and nursing mothers.
  • Current or prior history of brain metastases.
  • More than 12 months since their allogeneic stem cell re-infusion.
  • HIV+, Hepatitis BsAg+, Hepatitis C Ab+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Biological: CMV pp65 Specific T Cells
Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of CMV pp65 specific CD8+ T cells produced.
Time Frame: Pre-infusion.
Pre-infusion.
Development of grade III-IV GVHD or major organ toxicity.
Time Frame: Continuously for 100 days post-transplant.
Continuously for 100 days post-transplant.

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of CMV in peripheral blood.
Time Frame: Tested before and following transplant and infusion.
Tested before and following transplant and infusion.
Percentage of CD8+ T cells that are CMV pp65 specific.
Time Frame: Assessed weekly up to 6 months following T cell infusion.
Assessed weekly up to 6 months following T cell infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Kim Lyerly

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: H. Kim Lyerly, M.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (ESTIMATE)

February 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4138-07-10R5
  • IND 11649

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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