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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: Recruiting Phase 2 study of Adenovirus and Cytomegalovirus, sponsored by St. Jude Children's Research Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective of this clinical study is to evaluate the efficacy of adoptively transferred CMV- and ADV-specific haploidentical T-cells in patients who have undergone allogeneic HCT. This primary endpoint is defined as ≥1 log10 reduction in CMV and/or ADV viral load 4 weeks after VST infusion. When the initial viral load is \<1 log10 above the threshold of detection the endpoint will be a reduction to below the threshold of detection. The success rate will be evaluated using descriptive
Conditions Studied
Interventions
- DRUG VST infusion
- DEVICE CliniMACS
Study Locations (1)
Tennessee
- St . Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What NCT05664126 shows while recruiting
NCT05664126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, above the 24-participant average among 6 other Adenovirus trials with a reported enrollment target (75% higher).
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 a single indexed study location in 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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