NO_LONGER_AVAILABLENot Applicable

Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

Plain-language 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.

Who can participate

SexALL

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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

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

Trial details

NCT IDNCT02822495

SponsorAtara Biotherapeutics

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Epstein-Barr Virus (EBV) Infections trials