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

NCT05664126 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus
  • Adenovirus

Interventions

DRUG

VST infusion

single intravenous (IV) infusion.

DEVICE

CliniMACS

Cells infusions are prepared using the ClinMACS

Sponsors & Collaborators

Principal Investigators

  • Naik Swati, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664126 on ClinicalTrials.gov