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NCT05664126 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Adenovirus and Cytomegalovirus, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
Phase 2
Development phase
42
Enrollment target
1
Study location

NCT05664126 is a Phase 2 study of Adenovirus and Cytomegalovirus that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 42 participants, above the 24-participant average among 6 other Adenovirus trials with a reported enrollment target (75% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05664126, a Phase 2 study of Adenovirus and Cytomegalovirus, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

RECRUITING
Registry status
Phase 2
Development phase
42 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG VST infusion
  • DEVICE CliniMACS

Study Locations (1)

Tennessee

  • St . Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2023-08-01
Est. Completion 2029-12-31
Phase Phase 2

What the Registry Record Tells You About NCT05664126

The ClinicalTrials.gov registry entry for NCT05664126 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 24-participant average among 6 other Adenovirus trials with a reported enrollment target (75% higher). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Adenovirus appearing as the primary indexed condition, and to 2 interventions - of which VST infusion is the first listed.

NCT05664126 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT05664126 about?

NCT05664126 is a clinical study titled "Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation". 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 VST...

What is the current status of trial NCT05664126?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2023-08-01. Estimated completion is 2029-12-31.

What conditions does trial NCT05664126 study?

This clinical trial studies the following conditions: Adenovirus, Cytomegalovirus.

What interventions are being tested in trial NCT05664126?

The interventions under investigation include: VST infusion (DRUG), CliniMACS (DEVICE).

Who is sponsoring clinical trial NCT05664126?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05664126 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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