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Virus Therapy

VST Therapy for Viral Infections

Phase 1

Waitlist Available

Led By Catherine Bollard, MD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cells administered as treatment of persistent or relapsed reactivation or infection

Received prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, single/double cord blood or PBSC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will use rapidly generated, allogeneic most closely HLA-matched multivirus-specific T cell lines to treat patients with persistent virus infections despite conventional therapy.

Who is the study for?

This trial is for allogeneic hematopoietic stem cell transplant recipients with persistent viral infections (EBV, CMV, adenovirus) despite treatment. Participants must have stable vital signs and organ function, not be pregnant, and able to consent. Excluded are those with uncontrolled infections or malignancies, recent immunosuppressive therapies or donor lymphocyte infusions.Check my eligibility

What is being tested?

The study tests if HLA-matched virus-specific T cell lines (VSTs) from a bank can fight viruses in transplant patients who haven't responded to standard antiviral treatments. It checks the safety of these ready-made VSTs and their effectiveness against EBV, CMV, and adenovirus.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to mismatched cells leading to symptoms like fever or fatigue; however specific side effects will be monitored closely given the novel nature of this therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving cell therapy for a persistent or relapsed infection.

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I have had a stem cell transplant from a donor.

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I am receiving early treatment for infections with EBV, CMV, or adenovirus.

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I am taking 0.5 mg/kg/day or less of prednisone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assessments of patients with adverse events after VSTs infusion.

Secondary outcome measures

Assessments of Antiviral Immunity

Assessments of viral load response to the CTL infusion

Trial Design

1Treatment groups

Experimental Treatment

Group I: VSTs against three virusesExperimental Treatment1 Intervention

Patients will receive 2 x 107 partially HLA-matched VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused after discussion with the principal investigator, patient and/or guardian and the treatment team. If participants have a partial response (as defined by a 50% fall in viral load) they are eligible to receive up to 4 additional doses from day 28 after the initial infusion and at 2 weekly intervals thereafter.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor

13 Previous Clinical Trials

300 Total Patients Enrolled

1 Trials studying Viral Infections

36 Patients Enrolled for Viral Infections

Catherine Bollard, MDPrincipal InvestigatorChildren's National Research Institute

6 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

VSTs (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02510417 — Phase 1

Viral Infections Research Study Groups: VSTs against three viruses

Viral Infections Clinical Trial 2023: VSTs Highlights & Side Effects. Trial Name: NCT02510417 — Phase 1

VSTs (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02510417 — Phase 1

Frequently Asked Questions

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

Can I register to take part in this trial?

"To be eligible for this clinical experiment, applicants must have viral medical conditions and fall between 4 weeks to 45 years of age. The study is aiming to accept around 31 patients in total."

Answered by AI

Is enrollment in this study currently open?

"The public records of clinicaltrials.gov suggest that this investigation is no longer actively recruiting participants, as the study was first posted on October 28th 2014 and last updated August 30th 2022. Nevertheless, there are 832 other trials open for enrollment at present."

Answered by AI

Does the Food and Drug Administration recognize VST as a legitimate treatment?

"Due to minimal data supporting the efficacy and safety of VSTs, our team at Power assigned them a score of 1."

Answered by AI

Is this trial open to individuals aged 40 and above?

"According to the inclusion criteria, only those between 4 weeks and 45 years of age are eligible. There are a total of 220 trials for minors under 18 while 650 trials exist for seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allogeneic Virus-specific T Cell Lines (VSTs)

Catherine Bollard 2014. "Allogeneic Virus-specific T Cell Lines (VSTs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02510417.