Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma
About this trial
This is an expanded access trial for Epstein-Barr Virus (EBV) Infections focused on measuring Epstein-Barr Virus (EBV), Solid Organ Transplant (HCT), Hematopoietic Cell Transplant (SOT), Primary Immunodeficiency (PID), Acquired Immunodeficiency (AID), Epstein-Barr Virus-associated Lymphoma, HIV/AIDS Lymphoma, Rheumatoid Arthritis and Lymphoma, Allogeneic, Off-The-Shelf T-cell Immunotherapy, Tumor Necrosis Factor (TNF)-alpha Inhibitors and Lymphoma, Inflammatory Bowel Disease and Lymphoma, Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL), Epstein-Barr Virus+ associated Nasopharyngeal Carcinoma (EBV+ NPC), Epstein-Barr Virus+ associated Leiomyosarcoma (EBV+ LMS)
Eligibility Criteria
Inclusion Criteria:
Any of the following diagnoses of EBV+ malignancies or disease:
- EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
- EBV+ PTLD following solid organ transplant (SOT)
- Persistent EBV viremia and known or suspected immunodeficiency
- EBV+ LPD that has developed in the setting of an AID
- EBV+ LPD that has developed in the setting of a known or suspected PID
- EBV+ LMS
- EBV+ NPC
- The evidence of EBV positivity
- 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.
- Not eligible for any other Atara clinical development study
- For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be in morphologic remission
Adequate organ function per the following:
- Absolute neutrophil count >= 500/μL, with or without cytokine support
- Platelet count >= 20,000/μL, with or without transfusion support
- Participant or participant's representative is willing and able to provide written informed consent
Exclusion Criteria:
- Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma
- 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
- Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or equivalent)
- Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat
- 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
- Pregnancy
- 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