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Virus Therapy

Virus Specific T-cell (VST) infusion for Cytomegalovirus (ACES Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Michael Pulsipher, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months
Awards & highlights

ACES Trial Summary

This trial will test whether VSTs are safe and effective in controlling three viruses in different types of patients.

Who is the study for?
This trial is for patients who've had a stem cell transplant or have primary immunodeficiency with persistent or relapsed CMV, EBV, or adenovirus infections despite standard treatment. Eligible participants must be able to reduce steroid use and not be pregnant if applicable. Those with uncontrolled cancer, recent monoclonal antibody therapy, other cellular therapies, or uncontrolled infections are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of virus-specific T-cell (VST) infusions in controlling EBV, CMV, and adenovirus infections in individuals post-stem cell transplant or those with primary immunodeficiency disorders who haven't responded well to standard treatments.See study design
What are the potential side effects?
Potential side effects of VST infusion may include reactions at the infusion site like pain or swelling, fever, fatigue, headache and possible worsening of underlying conditions due to immune response. Each patient's experience can vary.

ACES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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
Efficacy of VST at 30 days as measured by viral load
Feasibility to identify suitable HLA matched VST products
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Effects on Clinical Signs of Viral Infection
Persistence of infused VSTs
Reconstitution of Antiviral Immunity following VST infusions
+1 more

ACES Trial Design

1Treatment groups
Experimental Treatment
Group I: Virus specific T cell lines (VSTs) against three virusesExperimental Treatment1 Intervention
The study will evaluate whether partially-HLA matched allogeneic multivirus-specific VSTs, activated using overlapping peptide libraries spanning immunogenic antigens from CMV, adenovirus and EBV, will be safe and produce anti-viral effects in immunodeficient recipients infected with one of more of the targeted viruses that are persistent despite conventional anti-viral therapy.

Find a Location

Who is running the clinical trial?

Michael Pulsipher, MDLead Sponsor
4 Previous Clinical Trials
184 Total Patients Enrolled
Michael Keller, MDStudy ChairChildren's National Research Institute
3 Previous Clinical Trials
63 Total Patients Enrolled

Media Library

Virus Specific T-cell (VST) (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03475212 — Phase 1 & 2
Cytomegalovirus Research Study Groups: Virus specific T cell lines (VSTs) against three viruses
Cytomegalovirus Clinical Trial 2023: Virus Specific T-cell (VST) Highlights & Side Effects. Trial Name: NCT03475212 — Phase 1 & 2
Virus Specific T-cell (VST) (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03475212 — Phase 1 & 2
Cytomegalovirus Patient Testimony for trial: Trial Name: NCT03475212 — Phase 1 & 2

Frequently Asked Questions

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

Is there additional research exploring the efficacy of Virus Specific T-cell (VST) infusion?

"The first studies of Virus Specific T-cell (VST) infusion began in 2018 at Columbia University Medical Center. To date, 0 trials have reached completion with 1 actively recruiting study that is mainly conducted out of Durham, North carolina."

Answered by AI

How many healthcare facilities are conducting this experiment?

"Currently, this clinical trial is occurring in 30 different centres across the United States. These sites are based in Durham, Chicago and Phoenix as well as 27 other cities - it's advisable to pick a location close by so you can minimize travel costs if necessary."

Answered by AI

Are recruitment efforts ongoing for this research endeavor?

"As indicated by clinicaltrials.gov, this medical research is no longer recruiting patients and has not done so since March 2nd 2022. Despite the closure of this trial, there are 825 other trials that remain actively searching for participants."

Answered by AI

What is the current capacity of this medical study?

"This experiment is not seeking participants at this time; it was initially posted on June 20th 2018 and most recently updated on March 2nd 2022. However, there are 824 clinical trials involving epstein barr virus infections currently recruiting patients as well one study specifically looking for individuals to receive a Virus Specific T-cell (VST) infusion."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
California
Arizona
Other
How old are they?
18 - 65
What site did they apply to?
Phoenix Children's Hospital
Stanford Lucile Packard Children's Hospital
Emory University/Children's Healthcare of Atlanta
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been dealing with CFS for over 3 years now and it seems to be getting worse. I was just diagnosed with high levels of EBV anti bodies.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation
Michael Pulsipher, MD 2018. "Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03475212.
~9 spots leftby Apr 2025
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