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

Phase 2

Recruiting

• Conditions: Epstein-Barr Virus Infections; Primary Immune Deficiency Disorder
• Interventions: Drug: cytotoxic t-lymphocytes

• Registration Number: NCT03266653
• Lead Sponsor: New York Medical College

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Study Start: 2020-07-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refractory EBV	cytotoxic t-lymphocytes	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)

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Patients will be followed for 12 weeks after each infusion	Patients will be monitored for adverse events related to the infusion of EBV CTLs
Incidence of Response to Treatment [Efficacy]	Patients will be followed for 12 weeks after each infusion	Patients will be followed for improvement in viral infection by monitoring EBV PCR weekly for response to treatment with CTLs

Trial Locations

Locations (8)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Nationwide Children's Hosptial; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hosptial Los Angeles; 🇺🇸 Los Angeles, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Medical College of Wisconsin/Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

New York Medical College; 🇺🇸 Valhalla, New York, United States