RecruitingPhase 2NCT02479698

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection


Sponsor

M.D. Anderson Cancer Center

Enrollment

100 participants

Start Date

Jul 23, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing specially engineered immune cells (called cytotoxic T lymphocytes, or CTLs) as a treatment for patients who have serious viral infections caused by BK virus or JC virus — viruses that can cause severe kidney damage or brain infection in people with weakened immune systems, certain cancers, or organ transplants. **You may be eligible if...** - You are 2 years of age or older - You have a weakened immune system (such as from a transplant, HIV/AIDS, or cancer treatment), OR you have JC virus brain infection (called PML), OR you have Merkel cell cancer - Blood or urine tests confirm a BK or JC virus infection, or kidney inflammation due to BK virus - Your current antiviral medications have not worked - You are able to reduce steroid medications to a low dose - Women of childbearing age must have a negative pregnancy test and agree to use contraception **You may NOT be eligible if...** - You are currently on high-dose steroids - You received certain powerful immune-suppressing treatments very recently - You have other active, uncontrolled infections (beyond HIV) - You have severe acute graft-versus-host disease (grades II to IV) after a bone marrow transplant Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic BK-specific Cytotoxic T-lymphocytes

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT02479698


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