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Administration of Virus-Specific Cytotoxic T-Lymphocytes

NCT00590083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-02-19

No results posted yet for this study

Summary

The main purpose of this study is to see if these T-lymphocytes are safe. To make these Ad-specific T lymphocytes the investigators will obtain blood from the stem cell donor and transfer Ad into another type of blood cell, called monocytes. These cells can then stimulate the T lymphocytes and train them to kill cells infected with Ad. The investigators will then grow these Ad-specific T lymphocytes by more stimulation with Ad-infected monocytes and a third type of blood cell called a B lymphoblast from the donor. After testing the T -lymphocytes, the investigators will inject them into patients after transplant who are at high risk of serious Ad virus infection. The investigators will make sure the injected cells are safe and see if they affect the growth and behavior of adenoviruses in the patient's own body.

Conditions

  • Adenovirus Infection

Interventions

BIOLOGICAL

CTL administration

Adenovirus specific T cells will be given by intravenous injection from day 30 post transplant. One infusion of Adenovirus-specific CTL given to patients at risk for Adenoviral disease after matched or mismatched unrelated or matched or mismatched related donor stem cell transplant. Four dose levels will be explored. The lowest level will be 1x dose of 5x10e6cells/m2 and the highest will be 1x dose of 1.35x10e8/m2.

Sponsors & Collaborators

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Catherine Bollard, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590083 on ClinicalTrials.gov