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EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection
Trial Status: active
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
Inclusion 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 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03266653.
Locations matching your search criteria
United States
Colorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Name Not Available
Indiana
Indianapolis
Riley Hospital for Children
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center