Last updated on April 2018

T Cell Therapy for Adenovirus in Immunocompromised Patients


Brief description of study

If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help to control adenovirus. Researchers also want to learn about the safety of giving CTLs to patients with adenovirus.

CTLs are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections.

This is an investigational study. The use of CTLs to treat adenovirus is not FDA approved. At this time, CTLs are only being used to treat infections in research studies.

Up to 16 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Study Description

CTL Administration:

If you are found to be eligible to take part in this study, you will receive the CTLs by vein (also called an infusion) over about 30 minutes. You will stay in the clinic for about 1 hour after the CTL infusion so that you can be checked for any side effects you may have.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

If your doctor thinks it is needed, you may receive additional CTL infusions.

Length of Study:

You will take part in this study for 12 months after your final CTL infusion. Your participation on this study will be over when you have completed the 12-month visit.

You will no longer be able to receive the CTL infusion(s) if the disease gets worse, if intolerable side effects occur, if you need medical treatment not allowed in this study, or if you are unable to follow study directions.

Study Visits:

Since you may have more than one CTL infusion, the study visit time points are based on the time of your last CTL infusion.

Within 72 hours before the CTL infusion:

  • You will have a physical exam.
  • Blood (about 3 tablespoons) will be drawn for routine testing and to test for adenovirus.
  • Urine will be collected for routine tests.
  • You will have a chest x-ray.

One (1) time each during Weeks 1-4, and then at 45 days and about 3, 6, and 12 months after each CTL infusion:

  • You will have a physical exam.
  • You will have standard of care tests to check the status of graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted).
  • Blood (about 4 tablespoons) will be drawn for routine testing, to check for adenovirus, and to test the effect of the CTLs on adenovirus and your immune system.
  • Urine will be collected for routine tests.

If you and the study doctor agree, you may be able to have the tests and procedures listed above at a clinic near your home. Please talk to the study staff about this possible option.

Clinical Study Identifier: NCT03425526

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University of Texas MD Anderson Cancer Center
Houston, TX United States
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