Expanded Access Protocol for Tabelecleucel in Subjects With EBV-Associated Viremia or Malignancies

Inclusion Criteria:

1. Any of the following diagnoses of EBV+ disease:

1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) or solid organ
transplant (SOT) and who cannot be treated under protocols designed to support
drug development or registration

2. Persistent EBV viremia as evidenced by 2 serial serum EBV deoxyribonucleic acid
(DNA) assays showing detectable EBV viremia at least 4 weeks apart, and known or
suspected immunodeficiency, or EBV viremia with a history of prior EBV+
malignancy

3. EBV+ LPD that has developed in the setting of an AID

4. EBV+ LPD that has developed in the setting of a known or suspected PID

2. Evidence of EBV positivity as follows:

1. Biopsy showing EBV+ disease, OR

2. A combination of circulating EBV DNA AND radiographic appearance consistent with
an EBV+ malignancy, if biopsy is not clinically feasible, OR

3. For EBV viremia only, fulfillment of inclusion criteria 1b

3. Relapsed or refractory disease, which is defined as:

1. In patients with PTLD following HCT: relapsed after or refractory to reduction of
immunosuppression and an anti-CD20 monoclonal antibody (unless investigator
determines tumor to be CD20-) as a single agent or in combination with
chemotherapy. Patients with CD20- disease must have failed chemotherapy alone.

2. In patients with PTLD following SOT: relapse after or refractory to reduction of
immunosuppression, an anti-CD20 monoclonal antibody (unless investigator
determines tumor to be CD20-) plus anthracycline based chemotherapy. Patients
with CD20- disease must have failed chemotherapy alone.

3. In patients with EBV viremia: Viremia that persists or recurs despite therapy
with an anti-CD20 monoclonal antibody

4. In patients with PID LPD: relapsed after or refractory to an anti-CD20 monoclonal
antibody (unless investigator determines tumor to be CD20-) as a single agent or
in combination with a chemotherapy

5. In patients with AID LPD: have failed at least two prior lines of therapy, one of
which is an anti-CD20 monoclonal antibody (unless investigator determines tumor
to be CD20-) plus anthracycline based chemotherapy (Note: Remission consolidation
with an autologous or allogeneic stem cell transplant will not be considered as a
separate line of therapy).

4. Not eligible for any other studies supporting development of tabelecleucel

5. For patients with PTLD in the allogeneic HCT setting, the underlying disease for which
allogeneic HCT was performed is in morphologic remission

6. Adequate organ function per the following:

1. Absolute neutrophil count ≥ 500/μL, with or without cytokine support

2. Platelet count ≥ 20,000/μL, with or without transfusion support

7. Patient or patient's representative is willing and able to provide written informed
consent

Exclusion Criteria:

1. Burkitt's lymphoma, classical Hodgkin's lymphoma, plasmablastic lymphoma, or any
T-cell lymphoma

2. Any investigational therapy received within 4 weeks prior to Cycle 1 Day 1, except for
therapy that is outside of 5 half-lives from the most recent dose to Cycle 1 Day 1

3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1
mg/kg/day, as prednisone equivalent

4. Need for vasopressor or ventilatory support, unless deemed to be caused by the
EBV-driven process that tabelecleucel is intended to treat

5. Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or
T-cell immunotherapy (donor lymphocyte infusion, other CTLs) ≤ 4 weeks prior to Cycle
1 Day 1

6. Pregnancy

7. Female of childbearing potential or male with a female partner of childbearing
potential unwilling to use a highly effective method of contraception, except when, in
the opinion of the treating physician in consultation with the medical monitor, the
risk/benefit of tabelecleucel therapy favors proceeding

8. Inability to comply with protocol procedures