drugset / Trial / NCT02822495
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
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.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tabelecleucel | Cell therapy | 1.6e+06 cells/kg | Intravenous |
| Subject | tabelecleucel | Cell therapy | 2e+06 cells/kg | Intravenous |
Indications
Epstein-Barr virus infection
Epstein-Barr virus-associated lymphoproliferative disorder
disease related to hematopoietic stem cell transplant
disease related to solid organ transplantation
immunodeficiency-associated lymphoproliferative disease
leiomyosarcoma
lymphoma
lymphoproliferative syndrome
nasopharyngeal carcinoma
post-transplant lymphoproliferative disease