RecruitingPhase 2NCT05664126

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

Sponsor

St. Jude Children's Research Hospital

Enrollment

42 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Adenovirus Cytomegalovirus

Summary

The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection. Primary objective To determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and/or ADV viral load in the peripheral blood 4 weeks after VST infusion. When the initial viral load is \<1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection. Secondary objectives * Determine the safety of VSTs when used to treat CMV and/or ADV viremia post-HCT. * Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion. * Assess the persistence of response for 6 months post-infusion.

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called virus-specific T-cells (VSTs) for children and young adults who have received a stem cell transplant (hematopoietic cell transplantation, HCT) and have developed stubborn viral infections — specifically cytomegalovirus (CMV) and/or adenovirus (ADV) — that are not responding to standard antiviral drugs. VSTs are immune cells grown from a family donor that are trained to fight these specific viruses. You may be eligible if (patient)... - You have had a haploidentical HCT or matched-sibling/matched-unrelated donor HCT - You have CMV and/or adenovirus in your blood that has not responded to at least 14 days of antiviral treatment - You do not have active graft-versus-host disease (GVHD) - A haploidentical donor is available for T-cell collection - Your heart, liver, kidney, and lung function meet the minimum requirements You may NOT be eligible if (patient)... - You have active GVHD - You are pregnant - You are on high-dose steroids (above 0.5 mg/kg prednisone equivalent) - You received a Donor Lymphocyte Infusion within the past 4 weeks - You have other severe uncontrolled infections (bacterial or fungal) 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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