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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days post culture initiation

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

GVHD, skin

GVHD, stomach

GVHD, sigmoid colon & rectum

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,549 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

Frequently Asked Questions

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

What are the risks associated with Viral Specific T-cells (VSTs)?

"While there is some data supporting the safety of Viral Specific T-cells, it is not yet clear if they are effective. Given this, our team scored VSTs as a 2."

Answered by AI

If a patient were interested, could they enroll in this clinical trial today?

"Yes, that is correct. The trial was first advertised on 8/18/2020 and is currently ongoing with a target of recruiting 100 patients from 1 location."

Answered by AI

How many people can be in this trial at one time?

"Yes, according to the information available on clinicaltrials.gov, this study is looking for more participants. The trial was originally posted on August 18th 2020 and updated April 7th 2022. They are aiming to enroll 100 people total from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant

2020. "Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04331275.

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