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

ConditionsEpstein-Barr Virus InfectionsPrimary Immune Deficiency Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-79
SponsorNew York Medical College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

intolerance to rituximab Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • cytotoxic t-lymphocytes

    Drug

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Refractory EBVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
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

Time frame
Patients will be followed for 12 weeks after each infusion

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York Medical College

Lead sponsor

Children's Hospital of Philadelphia

Collaborator

Medical College of Wisconsin

Collaborator

Nationwide Children's Hospital

Collaborator

Indiana University

Collaborator

Washington University School of Medicine

Collaborator

University of California, Los Angeles

Collaborator

University of California, San Francisco

Collaborator

Source ClinicalTrials.gov
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