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Virus Therapy

VST Infusion for Post-Transplant Viral Infections (VSTs Trial)

Phase 1 & 2
Recruiting
Led By Michael Grimley, MD
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
Recipient must be at least 21 days after stem cell infusion
Clinical status must allow tapering of steroids to 0.5mg/kg prednisone or other steroid equivalent
Must not have
Uncontrolled relapse of malignancy
Uncontrolled bacterial or fungal infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days after infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people who have undergone or will undergo an allogeneic stem cell transplant. The investigators are testing whether VSTs can help reduce the risk of viral infections or help treat viral infections that occur after transplant.

Who is the study for?
This trial is for people who've had or will have a stem cell transplant from another person and are struggling with viral infections post-transplant. They must have stable white blood cell counts, be able to reduce steroid use, and be at least 21 days past their stem cell infusion. It's not for those recently treated with certain immune suppressants, experiencing severe graft-versus-host disease, uncontrolled bacterial/fungal infections, or cancer relapse.
What is being tested?
The study tests the effectiveness of infusing donor-derived T-cells that specifically target viruses in patients after allogeneic stem cell transplants. These special cells aim to combat common but potentially deadly viral infections that can occur when someone's immune system is weakened by a transplant.
What are the potential side effects?
While specific side effects aren't listed here, similar treatments may cause reactions at the infusion site, flu-like symptoms, fatigue, risk of other infections due to immune response changes and potential complications related to how these cells interact with existing medications or conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It has been at least 21 days since my stem cell infusion.
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I can reduce my steroid use to a low dose.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has returned and is not under control.
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I do not have any untreated bacterial or fungal infections.
Select...
I am experiencing moderate to severe symptoms from a recent transplant.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of GVHD associated with VST infusion
Percentage of patients who do not have infusional toxicity
Successful production of viral specific T-cells
Secondary study objectives
Presence of viral-specific T-cells
Viral burden

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Viral Specific VST InfusionExperimental Treatment1 Intervention
Viral reactivation or infection. VST Reinfusion required.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,564,593 Total Patients Enrolled
Hoxworth Blood CenterOTHER
6 Previous Clinical Trials
873 Total Patients Enrolled
Michael Grimley, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Viral specific VST Infusion (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02048332 — Phase 1 & 2
Viral Infections Research Study Groups: Viral Specific VST Infusion
Viral Infections Clinical Trial 2023: Viral specific VST Infusion Highlights & Side Effects. Trial Name: NCT02048332 — Phase 1 & 2
Viral specific VST Infusion (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02048332 — Phase 1 & 2
~122 spots leftby Jan 2027
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