Epstein-Barr Virus Specific T-Lymphocytes for EBV Infection

Jessie Alexander, Palo Alto, CA
EBV Infection+2 More ConditionsEpstein-Barr Virus Specific T-Lymphocytes - Biological
1 - 60
All Sexes

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.

Eligible Conditions
  • Epstein-Barr Virus (EBV) Infection
  • Cytomegalovirus (CMV)
  • Adenovirus

Treatment Effectiveness

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Baseline through study completion, an average of 1 year

Baseline through Day 180
Chronic Graft versus host disease
Year 1
Immune Reconstitution
Viral load by Polymerase Chain Reaction (PCR)
Viral load from Bronchoalveolar lavage (BAL)
Viral load from Respiratory Viral Panel (RVP)
Viral load from Stool
Viral load from Urine
Viral load from fluid/tissue
Year 1
Clinical response to viral specific infusion
Day 30
CTCAE Grade 4/5 Adverse Events
Day 90
Grade III-IV Acute Graft versus host disease
Year 1
Antiviral Agents
Year 1
1 Year Survival (continuous)
Month 6
6-month Survival (dichotomous)

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Viral Specific T-Lymphocytes
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Epstein-Barr Virus Specific T-Lymphocytes · No Placebo Group · Phase 1 & 2

Viral Specific T-LymphocytesExperimental Group · 3 Interventions: Epstein-Barr Virus Specific T-Lymphocytes, Cytomegalovirus Specific T-Lymphocytes, Adenovirus Specific T- Lymphocytes · Intervention Types: Biological, Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through study completion, an average of 1 year

Who is running the clinical trial?

Jessie L. AlexanderLead Sponsor
Jessie BarnumLead Sponsor
Jessie Alexander, MDPrincipal InvestigatorStanford University
Jessie Barnum, MD5.01 ReviewsPrincipal Investigator - UPMC Children's Hospital of Pittsburgh
University of Pittsburgh
1 Previous Clinical Trials
6 Total Patients Enrolled

Eligibility Criteria

Age 1 - 60 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.