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Epstein-Barr Virus InfectionsPhase 2NCT03266653

EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection

A Phase 2 study testing cytotoxic t-lymphocytes in people with Epstein-Barr Virus Infections and Primary Immune Deficiency Disorder, run by New York Medical College at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary… Read more about this study

Who is it for?
Ages 1 month to 79 years
What is being tested?
cytotoxic t-lymphocytes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
8 sitesUnited States
Study dates
7 Jul 2020to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 79 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult
  1. 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 AND/OR
  • Medical intolerance to anti-viral therapies including:
  • intolerance to rituximab Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.

Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) Age: 0.1 to 79.99 years Females of childbearing potential with a negative urine pregnancy test

2 Donor Eligibility 5.2.1 Related donor available with a T-cell response to the EBV MACS® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection.

  1. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor > 1 HLA A, B, DR match to recipient) with IgG positive to EBV and/or a T-cell response at least to the viral MACS® GMP PepTivator EBV Select (containing among other antigens, NA-1, LMP2A and BZLF-1).

AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).

AND Obtained informed consents by donor or donor legally authorized representative prior to donor collection.

3 Patient exclusion criteria:

A patient meeting any of the following criteria is not eligible for the present study:

Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of CTL infusion Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory EBV infection Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.

Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.

Known human anti-mouse antibodies

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mitchell Cairo, MD contact

914-594-2150

mitchell_cairo@nymc.edu

Lauren Harrison contact

6172857844

lauren_harrison@nymc.edu

8 sites in 1 country

United States8 sites, 8 recruiting

  • Johns Hopkins

    Baltimore, Maryland, 21287

    Kenneth Cooke, MD

    Recruiting

  • Nationwide Children's Hosptial

    Columbus, Ohio, 43205

    Dean Lee, MD, PhD, 614-722-3550, Dean.Lee@nationwidechildrens.org

    Recruiting

  • Children's Hosptial Los Angeles

    Los Angeles, California, 90027

    Neena Kapoor, MD, nkapoor@chla.usc.edu

    Recruiting

  • Medical College of Wisconsin/Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    Julie A Talano, MD, 414-955-4185, jtalano@mcw.edu

    Meredith Beversdorf, RN, (414) 266-5891, mbeversdorf@mcw.edu

    Recruiting

  • Children's Hospital of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Nancy Bunin, MD, 215-590-2255, buninn@email.chop.edu

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    Julia Chu, MD, Julia.Chu2@ucsf.edu

    Recruiting

  • Washington University

    St Louis, Missouri, 63130

    Shalini Shenoy, MD, shalinishenoy@wustl.edu

    Recruiting

  • New York Medical College

    Valhalla, New York, 10595

    Mitchell S Cairo, MD, 914-594-2150, mitchell_cairo@nymc.edu

    Mitchell S. Cairo, MD

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection With Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients

Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.

Funding Source: FDA OOPD

Being tested
cytotoxic t-lymphocytes
Medical subject headings
Epstein-Barr Virus Infections, Primary Immunodeficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cytotoxic t-lymphocytesDrug

    Also called CTLs

    EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.

Study groups in NCT03266653
Study groupRoleWhat they receive
Refractory EBVExperimentalPatients 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)
Receives: Drug: cytotoxic t-lymphocytes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Patients will be monitored for adverse events related to the infusion of EBV CTLs

    Measured: Patients will be followed for 12 weeks after each infusion

  2. Incidence of Response to Treatment [Efficacy]

    Patients will be followed for improvement in viral infection by monitoring EBV PCR weekly for response to treatment with CTLs

    Measured: Patients will be followed for 12 weeks after each infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start7 Jul 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All patients given identical treatment with CTLs for refractory EBV.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03266653
Sponsor's protocol ID
NYMC 581
Other IDs
FD006363
Status last verified
Oct 2026
First submitted
25 Aug 2017
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cytotoxic t-lymphocytes in people with Epstein-Barr Virus Infections and Primary Immune Deficiency Disorder, run by New York Medical College at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mitchell Cairo, MD (914-594-2150, mitchell_cairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Patients will be followed for 12 weeks after each infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03266653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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