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New treatment option for Cytomegalovirus
Official title Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation
ClinicalTrials.gov ID: NCT05664126
What this study is testing
What is VST infusion?
VST infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cytomegalovirus.
Also referred to as The product is a suspension of allogenic peripheral blood VSTs enriched based on their secretion of IFN-γ after stimulation with the appropriate antigen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- for Patients:
- Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the...
- Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy...
- Patients have no suspected or confirmed GVHD.
- Availability of haploidentical donor for isolation of virus-specific T-cells.
You likely can't join if
- for Patients:
- Active GVHD.
- Pregnancy.
- Inability to provide consent.
- Need for vasopressor or ventilatory support Patients receiving steroids \>0.5 mg/kg prednisone equivalent at the time of VST infusion
- Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.
See the full eligibility criteria
- for Patients:
- Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT...
- Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.
- Patients have no suspected or confirmed GVHD.
- Availability of haploidentical donor for isolation of virus-specific T-cells.
- Have not received a Donor Lymphocyte Infusion in the past 4 weeks.
- Female patients of childbearing age must have a negative pregnancy test.
- Subject, parent, or guardian are capable of giving signed informed consent.
- Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%.
- Patients must have a bilirubin less than or equal to 2.5mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.
- Patients must have an estimated glomerular 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 determination of the principal investigator precludes therapy with VST.
- Patients must have FVC \>50% predicted or able to 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 3 consecutive days. for donors
- Age ≥18 years.
- At least single haplotype matched (≥3/6) family member.
- Donor will be identical to the stem cell donor (Cohort A) or different from the stem cell donor (Cohort B).
- HIV negative.
- For females of childbearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND not lactating with intent to breastfeed.
- Regarding donation eligibility, is identified as either having completed the process of donor eligibility determination as outlined in 21CFR 1271 and agency guidance or does not meet 21CFR 1271 eligibility requirements...
- Identified recipient with CMV and/or ADV reactivation post-HCT.
- for Patients:
- Active GVHD.
- Pregnancy.
- Inability to provide consent.
- Need for vasopressor or ventilatory support Patients receiving steroids \>0.5 mg/kg prednisone equivalent at the time of VST infusion
- Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.
- Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion.
- Other severe uncontrolled concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.