Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells (NCT03798301) | Clinical Trial Compass
TerminatedPhase 1
Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells
Stopped: Slow accrual
United States3 participantsStarted 2020-02-06
Plain-language summary
The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections.
The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).
Participants will be followed for one year.
Who can participate
Age range
1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult or pediatric patient suffering from CMV reactivation/infections following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).
. Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time of T-cell transfer.
. Written informed consent given by patient or legal representative.
. Minimum patient age 1 month.
. Minimum weight 7 lbs.
. Female patients of childbearing age with negative pregnancy tests.
. Patient Karnofsky/Lansky Performance Status \>30%.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer
Timeframe: up to 21 days from enrollement
2
Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST
Timeframe: up to 21 days from enrollment
3
Feasibility: Successful production of CMV-VST from donors
Timeframe: up to 21 weeks from enrollment
4
Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion
Timeframe: up to 4 hours after CMV-VST infusion
5
Safety: Number of Subjects who experience newly occurring acute GVHD grade 1
Timeframe: up to 12 weeks from CMV-VST infusion
6
Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD
Timeframe: up to 12 weeks from CMV-VST infusion
7
Safety: Number of subjects experiencing chronic GVHD