BK With VST for Kidney Transplant Patients (NCT05042076) | Clinical Trial Compass
CompletedPhase 1
BK With VST for Kidney Transplant Patients
United States3 participantsStarted 2021-12-16
Plain-language summary
This study measures the safety, feasibility, and efficacy of viral-specific T cells (VST) against BK Virus (BKV) in adult kidney transplant recipients. Participants are expected to be on study for 52 weeks.
Who can participate
Age range
18 Years – 75 Years
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:
* Age18 ≤ 75 years
* Have BKV infection/viremia following kidney transplantation, where BKV viremia is defined as positive BKV qPCR (≥ 250 copies)
* Have evidence of invasive BKV infection (BK Nephropathy)
* Experience one of the following:
* New, persistent and/or worsening BKV-related symptoms, signs and/or markers of end organ compromise despite being on lower immunosuppressive medication
* Adverse effects of lower immunosuppressive medications (e.g., dnDSA, biopsy proven rejection)
* Eligible Donor
* Provide Written informed consent
Exclusion Criteria:
* Non-kidney organ transplant recipient
* Patient with acute rejection of the kidney allograft at time of T-cell transfer
* Patient receiving steroids (\>0.5 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer
* Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days prior to T-cell transfer
* Extra renal tissue invasive BK infection
* Concomitant enrollment in another clinical trial interfering with endpoints of this study
* Any medical condition which could compromise participation in the study according to the investigator's assessment
* Known HIV infection
* Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control during study treatment Note: Women of childbearing potential must have a negative urine pregnancy test at study…
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
Incidence of Adverse Events up to 4 hours post Cell Infusion
Timeframe: cell infusion is on study day 0, safety data collected up to 4 hours post injection
2
Incidence of Adverse Events up to 4 weeks of T-cell Transfer
Timeframe: up to 4 weeks
3
Incidence of newly occurring acute rejection of kidney allograft until Week 12 after T-cell transfer
Timeframe: up to 12 weeks
4
Incidence of de novo antibodies against kidney allograft donor (dnDSA) until Week 52 after T-cell transfer
Timeframe: up to 52 weeks
5
Incidence of newly occurring acute GVHD grade ≥1 or aggravation of pre-existing acute GVHD until Week 12 after T-cell transfer
Timeframe: up to 12 weeks
6
Incidence of newly occurring acute GVHD grade ≥1 from Day 0 to Week 12