← Back to Search

Virus Therapy

VST Therapy for Kidney Transplant Infection

Phase 1

Recruiting

Led By Sandesh Parajuli, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 75 years

Have BKV infection/viremia following kidney transplantation, where BKV viremia is defined as positive BKV qPCR (≥ 250 copies)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 52

Awards & highlights

Study Summary

This trial will test if VST cells are safe and effective against BKV in kidney transplant recipients.

Who is the study for?

Adults aged 18-75 who have had a kidney transplant and are now experiencing BK Virus infection, with symptoms worsening despite reduced immunosuppression. Participants must not be in other conflicting trials, pregnant or breastfeeding, unwilling to use birth control, or have certain medical conditions like HIV.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of using donor-derived T cells that target the BK Virus in adults who've received a kidney transplant. The study lasts for one year and aims to see if these T cells can help manage the virus.See study design

What are the potential side effects?

Potential side effects may include immune reactions as the body adjusts to new T cells, typical risks associated with cell transfers such as infections or graft rejection, but specific side effect profiles will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Select...

I have a BK virus infection after kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events up to 4 hours post Cell Infusion

Incidence of Adverse Events up to 4 weeks of T-cell Transfer

Incidence of de novo antibodies against kidney allograft donor (dnDSA) until Week 52 after T-cell transfer

+3 more

Secondary outcome measures

Amount of Time to 1 log change in BK viral load

Amount of Time to BKV clearance from Day 0 of T-cell transfer to first day of 2 subsequent negative BKV PCR studies

Incidence of successful production of BK Virus specific T lymphocyte (VST) from donors on intent-to-treat basis

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: BK with VSTExperimental Treatment1 Intervention

Adult patients with BKV infection and nephropathy (BKN) following kidney transplantation.

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,183 Previous Clinical Trials

3,167,567 Total Patients Enrolled

Sandesh Parajuli, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Jacques Galipeau, MDStudy DirectorUniversity of Wisconsin, Madison

5 Previous Clinical Trials

70 Total Patients Enrolled

Media Library

BK-specific T cells from Donor Lymphocytes (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05042076 — Phase 1

BK Virus Infection Research Study Groups: BK with VST

BK Virus Infection Clinical Trial 2023: BK-specific T cells from Donor Lymphocytes Highlights & Side Effects. Trial Name: NCT05042076 — Phase 1

BK-specific T cells from Donor Lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05042076 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be an enrollee in this clinical experiment?

"This clinical trial seeks to recruit 20 individuals suffering from a communicable illness between the age of 18 and 75. To meet all criteria, applicants must be infected with BKV Nephropathy, show evidence of viremia (defined as >250 copies on qPCR) despite being administered lower immunosuppressive medication; display new or worsening symptoms regardless of said medications; provide written informed consent for their donor; and have experienced adverse effects from their immunosuppressant drugs such as dnDSA or biopsy proven rejection."

Answered by AI

What outcomes is the research project attempting to achieve?

"This trial, monitored over a duration of one year, will investigate the Adverse Event rate within four hours following Cell Infusion. Among its secondary objectives are Overall Survival Rate (time from T-cell transfer to death or last follow-up), feasibility of BK specific T cell production on intent-to-treat basis, and amount of time required for clearance of BKV after day 0 T cell transfer as verified by two negative PCR tests made at least two weeks apart."

Answered by AI

Are there any openings for individuals to participate in this trial?

"Affirmative, according to the information accessible on clinicaltrials.gov this medical study is actively seeking participants. This trial was first announced in December 2021 and has gone through several updates since then; now, it seeks 20 patients from one research facility."

Answered by AI

Can potential risks be associated with BK-specific T cells from Donor Lymphocytes therapy?

"Due to the limited clinical data surrounding BK-specific T cells from Donor Lymphocytes, our team at Power assigned them a score of 1 for safety."

Answered by AI

Does the eligibility criteria of this medical study encompass individuals over 80 years old?

"To be eligible for this clinical trial, participants must range in age from 18 to 75. In addition, there are 201 distinct trials available for minors and 613 studies suitable for those aged 65 and above."

Answered by AI

What is the enrollment capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which was initially published on December 16th 2021, is presently attempting to recruit patients. Approximately 20 individuals need to be selected from 1 particular medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BK With VST for Kidney Transplant Patients

2021. "BK With VST for Kidney Transplant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05042076.

All > Kidney Transplant