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Virus Therapy

Viral Specific T-cells for Post-Transplant Viral Infections

Phase 2
Recruiting
Led By Stella Davies, MBBS, PhD
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 invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis
Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent
Must not have
Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion
Uncontrolled relapse of malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 - 100 days after transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether VSTs can help the body fight off viral infections and whether they are safe.

Who is the study for?
This trial is for individuals who've had a stem cell transplant from another person at least 21 days ago, can reduce steroid use to low levels, and aren't critically ill. It's not for those with active moderate-to-severe graft-versus-host disease, uncontrolled cancer relapse, or recent treatment with certain immune-suppressing drugs.
What is being tested?
The study tests whether giving viral specific T-cells (VSTs) on a schedule or as needed can prevent or treat viral infections after an allogeneic stem cell transplant. VSTs are designed to fight viruses that patients may be vulnerable to post-transplant.
What are the potential side effects?
Potential side effects of VST infusion could include reactions similar to blood transfusions, such as fever and chills. There might also be risks related to the immune system's response which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a CMV infection affecting my lungs, eyes, colon, or liver.
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I can reduce my steroid use to less than 0.5mg/kg.
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I have symptoms of a BK virus infection, like bladder pain or kidney issues.
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I do not have any severe illnesses that would make infusion treatments dangerous for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I received ATG or alemtuzumab treatment within the last 2 weeks.
Select...
My cancer has returned and is not under control.
Select...
I am experiencing moderate to severe symptoms of graft-versus-host disease.
Select...
My Alemtuzumab levels are above 0.15 before VST infusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 - 100 days after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 - 100 days after transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Treatment Failures

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: VSTs to TreatExperimental Treatment1 Intervention
VSTs will be given only if a viral infection develops.
Group II: VSTs to PreventExperimental Treatment1 Intervention
VSTs are given through an IV infusion 21-30 days after transplant to see if the VSTs will help prevent a viral infection.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,157 Total Patients Enrolled
Hoxworth Blood CenterOTHER
6 Previous Clinical Trials
1,443 Total Patients Enrolled
Stella Davies, MBBS, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Media Library

Viral Specific T-cells (VSTs) (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04230356 — Phase 2
Stem Cell Transplant Research Study Groups: VSTs to Prevent, VSTs to Treat
Stem Cell Transplant Clinical Trial 2023: Viral Specific T-cells (VSTs) Highlights & Side Effects. Trial Name: NCT04230356 — Phase 2
Viral Specific T-cells (VSTs) (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04230356 — Phase 2
~7 spots leftby Feb 2025
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