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 Phase 2 study at St. Jude Children's Research Hospital tests whether virus-specific T cells (immune cells trained to fight specific infections) collected from a partially matched family donor can safely and effectively treat cytomegalovirus (CMV) and/or adenovirus (ADV) infections that persist despite standard antiviral drugs in patients who have received a stem cell transplant. These persistent viral infections can be life-threatening in transplant patients whose immune systems are weakened. Patients who have undergone a haploidentical or matched donor transplant, have confirmed persistent CMV or ADV infection after at least 14 days of treatment, and have no active graft-versus-host disease are eligible. Participation involves receiving an infusion of the donor-derived virus-specific T cells and being monitored for viral load reduction and safety over 6 months. This summary was prepared to help patients understand the study in plain language.

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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