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Virus Therapy

EBV-specific CTLs for EBV Infection

Phase 2
Recruiting
Led By Mitchell Cairo, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly, Medical intolerance to anti-viral therapies including intolerance to rituximab
Related donor available with a T-cell response to the EBV MACS® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed for 12 weeks after each infusion
Awards & highlights

Study Summary

This trial will test whether related donor EBV-specific CTLs can be used to treat patients with EBV infection who have had an AlloHSCT, PID, or solid organ transplant.

Who is the study for?
This trial is for children and young adults aged 0.1 to 30 years with stubborn EBV infections after a stem cell or organ transplant, or those with primary immunodeficiencies. They must have tried antiviral treatments without success and not be on other experimental EBV studies, high-dose steroids, or have severe graft-versus-host disease.Check my eligibility
What is being tested?
The study tests if special immune cells called cytotoxic T-lymphocytes from related donors can fight off tough Epstein-Barr Virus (EBV) infections in patients who haven't responded well to standard treatments after receiving transplants.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the immune system's response to infused cells such as fever, fatigue, pain at infusion site, allergic reactions, and possibly more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an Epstein-Barr virus infection after a transplant and my current treatment isn’t working.
Select...
I have a donor whose T-cells react to the EBV infection I'm fighting.
Select...
I am younger than 80 years old.
Select...
I can do most of my daily activities without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed for 12 weeks after each infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed for 12 weeks after each infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Response to Treatment [Efficacy]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Design

1Treatment groups
Experimental Treatment
Group I: Refractory EBVExperimental Treatment1 Intervention
Patients with refractory EBV will get one dose of EBV specific CTLs. If they don't show a response based on EBV PCRs, patients may get up to another 4 doses of EBV-CTLs (5 doses maximum)

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalOTHER
338 Previous Clinical Trials
5,220,126 Total Patients Enrolled
Indiana UniversityOTHER
977 Previous Clinical Trials
983,293 Total Patients Enrolled
Washington University School of MedicineOTHER
1,928 Previous Clinical Trials
2,296,944 Total Patients Enrolled

Media Library

Cytotoxic T-lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03266653 — Phase 2

Frequently Asked Questions

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

How many facilities are offering participation in this clinical trial?

"This trial is available at 8 medical centres, including Washington University in Saint Louis, Children's Hospital of Pennsylvania in Philadelphia and Nationwide Children's Hosptial in Columbus."

Answered by AI

Who meets the criteria to partake in this investigation?

"This clinical trial is open to 20 participants between 1 Month and 30 years old who possess a Epstein-Barr Virus infection. Furthermore, the prospective patient requires an HLA A, B, DR match with their related donor of at least one level, as well as IgG positivity to EBV and/or a T-cell response measured by MACS® GMP PepTivator EBV Select (containing antigens such as NA-1, LMP2A and BZLF-1)."

Answered by AI

How many participants can the trial accommodate?

"To properly conduct this medical trial, 20 participants are needed who qualify for the study's eligibility requirements. Washington University in Saint Louis, Missouri and Children's Hospital of Pennsylvania in Philadelphia, Pennsylvania are two possible locations where individuals can sign-up to join."

Answered by AI

Is enrollment for this research study still being accepted?

"Yes, the available evidence suggests that this clinical trial is currently recruiting. The study was initially posted on July 7th 2020 and last updated September 27th 2022. 20 patients are needed across 8 medical locations to complete enrolment."

Answered by AI

Is this research inclusive of geriatric participants?

"This clinical trial seeks to enrol participants that are above 1 Month years and younger than 30."

Answered by AI

Has the FDA sanctioned cytotoxic t-lymphocytes for clinical use?

"The safety of cytotoxic t-lymphocytes was estimated to be a 2 since, in Phase 2 trials there is evidence suggesting it's benign albeit lacking efficacy data."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What site did they apply to?
Children's Hosptial Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Aug 2024