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CAR T-cell Therapy

VST Therapy for Post-Transplant Viral Infections

Phase 2
Waitlist Available
Led By Stella Davies, MBBS, PhD, MRCP
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.
Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days after infusion
Awards & highlights

Study Summary

This trial is studying the use of viral-specific T-lymphocytes (VSTs) to treat viral infections after solid organ transplant. VSTs are cells that are designed to fight viral infections. The cells are created from a blood sample that is collected from the study participant.

Who is the study for?
This trial is for individuals of any age over 1 day who have had a solid organ transplant and are now experiencing viral infections. Participants must have specific levels of viruses in their blood or evidence of invasive viral infection, be able to reduce steroid use, and travel to Cincinnati for the VST infusion.Check my eligibility
What is being tested?
The study tests Viral Specific T-cells (VSTs) as a treatment for post-transplant viral infections. These cells are engineered from the participant's blood to combat viruses that can cause complications after an organ transplant.See study design
What are the potential side effects?
Potential side effects may include typical immune responses such as fever or fatigue, but since this is investigational, exact side effects will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have symptoms or test results suggesting EBV-related lymph node issues.
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I have symptoms of a BK virus infection, such as painful urination or kidney issues.
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I have a CMV infection affecting my lungs, eyes, or colon.
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I am older than 1 day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days post culture initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days post culture initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful production of viral specific T-cells
Secondary outcome measures
Presence of viral-specific T-cells

Side effects data

From 2021 Phase 2 trial • 30 Patients • NCT03883906
4%
GVHD, skin
4%
GVHD, stomach
4%
GVHD, sigmoid colon & rectum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Viral Specific T-cells (VSTs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Viral Specific T-cells (VSTs)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Viral Specific T-cells (VSTs)
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,530,628 Total Patients Enrolled
5 Trials studying Viral Infections
1,410 Patients Enrolled for Viral Infections
Hoxworth Blood CenterOTHER
6 Previous Clinical Trials
1,281 Total Patients Enrolled
4 Trials studying Viral Infections
660 Patients Enrolled for Viral Infections
Stella Davies, MBBS, PhD, MRCPPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
2,116 Total Patients Enrolled

Media Library

Viral Specific T-cells (VSTs) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04331275 — Phase 2
Viral Infections Research Study Groups: Viral Specific T-cells (VSTs)
Viral Infections Clinical Trial 2023: Viral Specific T-cells (VSTs) Highlights & Side Effects. Trial Name: NCT04331275 — Phase 2
Viral Specific T-cells (VSTs) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04331275 — Phase 2
~2 spots leftby Sep 2024
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