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Virus Therapy

Viral Specific T-cells for Post-Transplant Viral Infections

Q: What are the FDA's thoughts on Viral Specific T-cells (VSTs) Treatment?

While there is some evidence that suggests this treatment may be safe, as it is only a Phase 2 trial, more data is needed to support the efficacy of Viral Specific T-cells (VSTs) Treatment. Consequently, our team has given it a score of 2.

Q: Are there any restrictions on who can sign up for this research project?

Yes, as of right now this study is still enrolling patients. The 180 needed participants will be recruited from a single site. This information comes from clinicaltrials.gov where the trial was first posted on 1/27/2021 and last edited on 3/17/2022.

Q: Could you please explain how many individuals are included in this clinical trial?

That is correct. The clinical trial was first posted on 1/27/2021 and was most recently edited on 3/17/2022. Currently, the study is enrolling 180 patients between 1 sites.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 - 100 days after transplant

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

I do not have any severe illnesses that would make infusion treatments dangerous for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 - 100 days after transplant

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

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

Primary outcome measures

Number of Treatment Failures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,411 Total Patients Enrolled

Hoxworth Blood CenterOTHER

6 Previous Clinical Trials

1,143 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

Frequently Asked Questions

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

What are the FDA's thoughts on Viral Specific T-cells (VSTs) Treatment?

"While there is some evidence that suggests this treatment may be safe, as it is only a Phase 2 trial, more data is needed to support the efficacy of Viral Specific T-cells (VSTs) Treatment. Consequently, our team has given it a score of 2."

Answered by AI

Are there any restrictions on who can sign up for this research project?

"Yes, as of right now this study is still enrolling patients. The 180 needed participants will be recruited from a single site. This information comes from clinicaltrials.gov where the trial was first posted on 1/27/2021 and last edited on 3/17/2022."

Answered by AI

Could you please explain how many individuals are included in this clinical trial?

"That is correct. The clinical trial was first posted on 1/27/2021 and was most recently edited on 3/17/2022. Currently, the study is enrolling 180 patients between 1 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

2021. "Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230356.

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