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Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C)

NCT02313857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-26

No results posted yet for this study

Summary

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections.

CMV can cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes.

Investigators want to see if they can use a kind of white blood cell called T cells to treat CMV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection.

Investigators have now generated CMV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target CMV.

In this study, investigators want to find out if the banked CMV-specific T cells derived from healthy donors are safe and can help to treat CMV infection.

The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food and Drug Administration (FDA).

Conditions

  • CMV Infections

Interventions

BIOLOGICAL

Viralym-C

Follow-up Assessments: The timing of follow-up visits is based on the date of Viralym-C infusion. If a patient has multiple Viralym-C infusions the schedule resets again at the beginning so follow up relates to the last Viralym-C infusion. Follow up will occur at 7 days, 14 days, 21 days, 28 days, 35 days, 42 days, 90 days, 180 days, and 365 days post enrollment.

Sponsors & Collaborators

  • AlloVir

    lead INDUSTRY

Principal Investigators

  • Bilal Omer, MD · The Methodist Hospital Research Institute

  • Swati Naik, MD · Texas Childrens Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-05-31
Completion
2018-02-28

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 NCT02313857 on ClinicalTrials.gov