Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

1. Patients with Adenovirus infections post allogeneic HSCT or with primary
immunodeficiencies with:

- Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of
appropriate anti-viral therapy and/or

- clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic
cystitis, colitis, hepatitis AND/OR

- Medical intolerance to anti-viral therapies including:

- grade 2 renal insufficiency secondary to cidofovir 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 30.00
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 ADV-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 Related donor available with a T-cell response to the viral MACS®
GMP PepTivator antigen(s) of adenovirus.

1. Original related allogeneic donor (if AlloHSCT recipient) if available:
confirmatory testing to respond to corresponding MACS GMP Peptivators

2. Third Party Related Allogeneic Donor: If original donor is not available or does
not have a T-cell response: third party allogeneic donor (family donor > 1 HLA A,
B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP
PepTivator antigen(s) of adenovirus.

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 adenovirus infection(s) 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