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Recruiting Phase 2 NCT03266653

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

Trial Parameters

Condition Epstein-Barr Virus Infections
Sponsor New York Medical College
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 1 Month
Max Age 79 Years
Start Date 2020-07-07
Completion 2026-12-31
Interventions
cytotoxic t-lymphocytes

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

Eligibility Criteria

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. a. Third Party Related Allogeneic Donor: If original donor is not available or doe

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