Anti-viral T-cell Therapy by Gamma Capture

Inclusion Criteria:

1. Patient, parent, or legal guardian must have given written informed consent,according to FDA guidelines. For pediatric subject who are developmentally able,assent or affirmation will be obtained, if feasible.

2. Male or female, 1 month through 75 years old, inclusive, at the time of informedconsent.

3. Prior allogeneic hematopoietic stem cell transplant (bone marrow, peripheral bloodstem cells, single or double cord blood), OR prior solid organ transplant (liver,kidney, lung and/or heart, intestinal, or multivisceral), OR diagnosis of primaryimmunodeficiency OR current/recent administration of immunosuppressive therapy forcancer or autoimmune disease.

4. Negative pregnancy test for females ≥10 years old or who have reached menarche,unless surgically sterilized. All females of childbearing potential and lactationmust agree to use an FDA approved method of birth control for the duration of theirparticipation.

5. Clinical status, at the time of consent, amendable to tapering of steroids to lessthan 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.

6. Diagnosis of Adenovirus, CMV, or EBV infection, persistent despite standard therapy.

A. Adenovirus Infection or Disease:

1. Active adenovirus infection: (i.e. gastroenteritis, pneumonia, hemorrhagic cystitis,hepatitis, pancreatitis, meningitis) defined as the demonstration of adenovirus bybiopsy specimen from affected site(s) (by culture or histology), or the detection ofadenovirus by culture, PCR or direct fluorescent antibody stain in fluid in thepresence of worsening or persistent clinical or imaging findings despite at least 14days of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or otheravailable pharmacological agents) OR

2. Refractory adenoviremia: defined as DNAemia >5000 copies/mL or <1 log decrease afterat least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, orother available pharmacological agents) OR

3. Intolerance of or contraindication to antiviral medications.

B.CMV Infection or Disease:

1. Active CMV infection: (i.e. pneumonia, meningitis, retinitis, hepatitis, hemorrhagiccystitis, and/or gastroenteritis) defined as the demonstration of CMV by biopsyspecimen from affected site(s) (by culture or histology) or the detection of CMV byculture, PCR or direct fluorescent antibody stain in fluid in the presence ofworsening or persistent clinical or imaging findings despite at least 14 days ofappropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or otheravailable pharmacological agents) OR

2. Refractory CMV viremia: defined as the continued presence of DNAemia, with ≥2,000IU/mL or <1 log decrease after at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents)OR

3. Intolerance of or contraindication to antiviral medications.

C. EBV Infection or Disease:

1. Biopsy proven lymphoma or posttransplant lymphoproliferative disease with EBVgenomes detected in tumor cells by immunocytochemistry (i.e. EBER positive) or insitu PCR, OR

2. Clinical or imaging findings consistent with EBV lymphoma and associated elevatedEBV viral load in peripheral blood in a patient where biopsy is deemed too highrisk, OR

3. Failure of antiviral therapy, as determined by one of the two bullets below afterthree weeks of anti-CD20 targeted therapy such as Rituximab.

i. There was an increase or less than 50% response at sites of lymphoma disease or lymphoproliferation.

ii. There was a rise or a fall of less than 50% in EBV viral load in peripheral blood of PTLD patients.

Exclusion Criteria:

1. Received Antithymocyte Globulin (ATG) or Alemtuzumab within 28 days ofviral-specific T cell infusion and a lack of evidence of T cell survival, defined by <10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered).

2. Active acute GVHD grades II-IV.

3. Received donor lymphocyte infusion, with the exception of a fraction of an umbilicalcord blood, within 14 days of viral-specific T cell infusion. Subjects receiving afraction of an umbilical cord blood within 14 days of the viral-specific T cellinfusion will not be excluded.

4. Active and uncontrolled relapse of malignancy (other than EBV+ post-transplantlymphoproliferative disorder or lymphoma).

5. Received an investigational product in the preceding 2 weeks (prior to infusion)that may impact Viral Specific T-cells (VST) survival.

6. Females of child bearing potential must not be lactating.

7. Past or current medical problems or findings from physical examination or laboratorytesting that are not listed above, which, in the opinion of the investigator, maypose additional risks to participation in the study, may interfere with theparticipant's ability to comply with study requirements, or that may impact thequality or interpretation of the data obtained from the study.