Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The primary objective of this protocol is to provide expanded access to tabelecleucel to
participants with Epstein-Barr virus-associated diseases and malignancies for whom there are
no other appropriate therapeutic options, and who are not eligible to enroll in clinical
studies designed to support the development and registration of tabelecleucel.
Phase
N/A
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
Inclusion Criteria:
1. Any of the following diagnoses of EBV+ malignancies or disease:
1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
2. EBV+ PTLD following solid organ transplant (SOT)
3. Persistent EBV viremia and known or suspected immunodeficiency
4. EBV+ LPD that has developed in the setting of an AID
5. EBV+ LPD that has developed in the setting of a known or suspected PID
6. EBV+ LMS
7. EBV+ NPC
2. The evidence of EBV positivity
3. Relapsed or refractory disease, defined as failure to achieve response (ie, complete
response or partial response) or recurrent disease following first line therapy, ie,
systemic therapy for EBV-related malignancy or viremia for which there are no
appropriate therapies.
4. Not eligible for any other Atara clinical development study
5. For participants developing PTLD following allogeneic HCT for acute leukemia, the
underlying acute leukemia must be 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. Participant or participant's representative is willing and able to provide written
informed consent
Exclusion Criteria:
1. Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell
lymphoma
2. Prior treatment with any investigational product within 4 weeks of first treatment
with tabelecleucel, or within 5 half-lives from the most recent dose to first
treatment with tabelecleucel
3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1
mg/kg/day of prednisone (or 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 cytotoxic T lymphocytes [CTLs])
<= 4 weeks prior to first treatment with tabelecleucel
6. Pregnancy
7. Female of childbearing potential or male with a female partner of childbearing
potential, either of whom are unwilling to use a highly effective method of
contraception