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

StatusRecruiting
PhasePhase 2
Started2023-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-02-19
Study Status v14
Re-verified, no change to tracked fields
2025-08-28
Study Status, Eligibility v13
Eligibility criteria+174 characters
[...] lomerular filtration rate (GFR) greater than 60mL/min/1.73m2 (may use estimated GFR that is auto calculated in the EHR). Patients must be free of severe infection which upon deter [...] therapy with VST. Patients must have FVC >50% predicted or if unableable to perform pulmonary function testing must maintain pulse oximetry saturation > 92% on room air. Gut diarrhea <1 liter/day (adults) or <20mL/kg/day (children) or if unable to quantify, then occurrence of 4 stools per day above baseline. Patients must have engrafted with an ANC >500 cells/mm3 for [...] lobulin or Alemtuzumab within 30 days of VST infus [...]
2025-03-18
Study Status, Eligibility v12
Eligibility criteria+137 characters
Inclusion Criteria for Patients: Patients who have undergone haploidentical HCT or a matche [...] ith CMV and/or ADV reactivation post-HCT. Exclusion Criteria for Patients: Active GVHD. Pregnancy. Inability to provide consent. Need [...] Thymoglobulin or Alemtuzumab within 30 days of VST infusion. Other concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.
2025-03-07
Study Identification, Study Status, Study Design v11
Primary completion date2026-12-31→2028-12-31
Completion date2027-12-31→2029-12-31
Enrollment target64→42
2024-10-15
Study Status v10
Re-verified, no change to tracked fields
Show 9 earlier versions
2024-03-13
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2024-01-17
Study Status, Study Design v8
Enrollment target35→64
2023-10-17
Study Status v7
Start dateestimated 2023-09→confirmed 2023-08-01
2023-08-22
Study Status v6
Start date2023-07→2023-09
2023-06-05
Study Status v5
Start date2023-06→2023-07
2023-05-03
Study Status v4
Start date2023-04→2023-06
2023-04-03
Study Status v3
Start date2023-03→2023-04
2023-03-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2023-02→2023-03
Study sitesdetails revised at 1 of 1 site
2023-01-09
Study Status v1
Start date2022-12→2023-02
2022-12-15
Original filing
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.
Trial Details
NCT Number NCT05664126
Lead Sponsor St. Jude Children's Research Hospital
Conditions Cytomegalovirus, Adenovirus
Enrollment 42 participants
Start Date 2023-08-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-23