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

NCT03266653 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: NYMC 581FD006363
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

Brief 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 immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD

Conditions

Epstein-Barr Virus Infections; Primary Immune Deficiency Disorder

Outcome Measures

Primary Outcomes (2)

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

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

  Patients will be followed for 12 weeks after each infusion

• 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

  Patients will be followed for 12 weeks after each infusion

Study Arms (1)

Refractory EBV

EXPERIMENTAL

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)

Drug: cytotoxic t-lymphocytes

Interventions

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.

Also known as: CTLs

Refractory EBV

Eligibility Criteria

• Age: 1 Month - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Medical College: lead
• 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

Study Sites (8)

Children's Hosptial Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

New York Medical College

Valhalla, New York, 10595, United States

RECRUITING

Nationwide Children's Hosptial

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical College of Wisconsin/Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mitchell Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Cairo, MD

CONTACT

914-594-2150; mitchell_cairo@nymc.edu

Lauren Harrison

CONTACT

6172857844; lauren_harrison@nymc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients given identical treatment with CTLs for refractory EBV.

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: July 7, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (8)