Overview
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
- 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 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