Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
NCT02822495 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2023-06-15
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.
Conditions
- Epstein-Barr Virus (EBV) Infections
- Lymphoproliferative Disorders
- EBV+ Associated Lymphoma
- EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Epstein-Barr Viremia
- Lymphoma, AIDS-related
- Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Primary Immunodeficiency (PID)
- Leiomyosarcoma (LMS)
- Nasopharyngeal Carcinoma (NPC)
- Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Acquired Immunodeficiency (AID)
- Solid Organ Transplant Complications
- Stem Cell Transplant Complications
Interventions
- BIOLOGICAL
-
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Aditi Mehta, DO · Atara Biotherapeutics
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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