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

Conditions:Infectious Disease, Infectious Disease, Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Age Range:Any - 30
Start Date:October 1, 2018
End Date:December 31, 2021
Contact:Mitchell Cairo, MD

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A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection With Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients

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) or with primary immunodeficiencies (PID).

1. Patients with Epstein-Barr virus infections post allogeneic HSCT or with primary
immunodeficiencies 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 30.99 years
The first 3 patients entered and possibly the next 3 patients entered will be limited to
age 12.0 - 30.99 years. See section 9.3.4 for age eligibility in the first 6 patients.

There will be a temporary hold until 45 days after the 3rd patient and possibly the 6th
patient has received their EBV-CTLs, The study should be reopened for patients of all ages
(0.1-30.99 years). (See Section 9.3.4 for instructions) 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.

1. Original related allogeneic donor (if AlloHSCT recipient) if available: confirmatory
testing to respond to corresponding MACS GMP Peptivator IgG positive EBV and/or EBV

2. 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
We found this trial at
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Mitchell S. Cairo, MD
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
Valhalla, NY
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Milwaukee, Wisconsin 53226
Phone: 414-955-4185
Milwaukee, WI
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Philadelphia, Pennsylvania
Phone: 215-590-2255
Philadelphia, PA
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