← Back to Search

Virus Therapy

Virus-Specific T-Cell Therapy for Infections

Phase 1 & 2
Waitlist Available
Led By Jessie Alexander, MD
Research Sponsored by Jessie L. Alexander
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical status, at time of consent, amendable to tapering of steroids to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion
Male or female, 1 month through 60 years old, inclusive, at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is looking at whether T cells can help people with adenovirus, CMV, or EBV infections who have received transplants or have weakened immunity.

Who is the study for?
This trial is for people aged 1 month to 60 years who have had a bone marrow or organ transplant, or have compromised immunity due to other conditions. They must be struggling with infections from adenovirus, CMV, or EBV despite standard treatments. Women of childbearing age need a negative pregnancy test.Check my eligibility
What is being tested?
The study tests if special immune cells called viral specific T-lymphocytes can fight off persistent infections by adenovirus, CMV, and EBV in those with weakened immune systems from transplants or other causes.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions related to immune cell infusions such as fever, chills, fatigue, headache, nausea and potential worsening of the underlying infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can reduce my steroid use to less than 1 mg/kg/day before cell therapy.
Select...
I am between 1 month and 60 years old.
Select...
I have had a stem cell or organ transplant, have a primary immunodeficiency, or am on immunosuppressive therapy.
Select...
I have a persistent Adenovirus, CMV, or EBV infection despite treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CTCAE Grade 4/5 Adverse Events
Grade III-IV Acute Graft versus host disease
Secondary outcome measures
1 Year Survival (continuous)
6-month Survival (dichotomous)
Antiviral Agents
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Viral Specific T-LymphocytesExperimental Treatment3 Interventions
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.

Find a Location

Who is running the clinical trial?

Jessie L. AlexanderLead Sponsor
Jessie BarnumLead Sponsor
Jessie Alexander, MDPrincipal InvestigatorStanford University

Media Library

Adenovirus Specific T-Lymphocytes (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04364178 — Phase 1 & 2
EBV Infection Research Study Groups: Viral Specific T-Lymphocytes
EBV Infection Clinical Trial 2023: Adenovirus Specific T-Lymphocytes Highlights & Side Effects. Trial Name: NCT04364178 — Phase 1 & 2
Adenovirus Specific T-Lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04364178 — 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 the participation of octogenarians permissible in this research?

"The requirements for this trial involve patients aged 1 Month to 60. In comparison, there are 216 trials designed with minors in mind and 651 studies catering to seniors."

Answered by AI

Are there currently any open opportunities to participate in this experiment?

"Affirmative. According to information found on clinicaltrials.gov, this trial is actively seeking out participants and was posted in August 12th 2020 with its last update being made two years later. A total of 25 patients are required for the study at 1 location."

Answered by AI

What is the current enrollment count for this trial?

"Affirmative. Clinicaltrials.gov's records suggest that this medical trial, which was launched on December 8th 2020 is presently recruiting participants. 25 individuals need to be recruited from a single healthcare facility."

Answered by AI

What aims are being sought after with this research endeavor?

"The objective of this research, calculated over a period spanning Day 0 to 30 days post-cellular infusion, is to measure the severity of Grade III-IV Acute Graft versus Host Disease. Secondary metrics include Viral Load as determined by Polymerase Chain Reaction (PCR), 6-month Survival Rates and Viral Load from Stool Samples."

Answered by AI

Am I a candidate for this investigation?

"This medical trial is recruiting 25 individuals, aged 1 month to 60 years old, with cytomegalovirus infections. In order for a patient to be eligible for enrollment they must provide informed consent (or assent if applicable), have a negative pregnancy test, demonstrate active adenovirus infection or refractory CMV viremia/adenoviremia and clinical findings consistent with EBV lymphoma. Furthermore, these participants must not be on high doses of steroids nor contraindicated from antiviral treatments prior to cellular infusion."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Jessie Alexander
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV
Jessie L. Alexander 2020. "Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04364178.
All > Ebv
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top