RecruitingPhase 1NCT03425526

Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease

Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Adenovirus Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients


Sponsor

M.D. Anderson Cancer Center

Enrollment

16 participants

Start Date

Mar 15, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests whether donor T cell therapy — infusing immune cells (T cells) taken from the original stem cell transplant donor — can help immunocompromised patients fight adenovirus infections. Adenovirus can cause severe, sometimes fatal infections in patients whose immune systems are weakened after a stem cell transplant. Standard antiviral medications often fail or cause significant toxicity in these patients. Participants receive specially selected T cells from their original donor that are designed to target adenovirus. This is a treatment study for a serious, hard-to-treat infection. You may be eligible if: - You are immunocompromised (any age, 1 year or older) - You have asymptomatic adenovirus viremia (two positive qPCR tests one week apart, or one test ≥1000 copies) OR probable/definitive adenoviral disease - Your original stem cell donor is available - Negative pregnancy test if you are a woman of childbearing potential You may NOT be eligible if: - You are receiving prednisone >0.1 mg/kg/day or have received ATG within 14 days or DLI/Campath within 28 days - You have other uncontrolled infections (bacterial infections progressing despite therapy, or fungal infections progressing despite antifungals) - You have active acute graft-versus-host disease (GVHD) Grade 2 or higher Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03425526


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