NCT02822495

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

NO LONGER AVAILABLE Last updated 15 June 2023

What this trial tests

trial testing tabelecleucel in Epstein-Barr Virus (EBV) Infections. No longer available.

Quick facts

Lead sponsor	Atara Biotherapeutics
Status	NO LONGER AVAILABLE
Study type	EXPANDED_ACCESS

Drugs / interventions tested

• tabelecleucel — full drug profile →

Conditions studied

• Epstein-Barr Virus (EBV) Infections — all drugs for Epstein-Barr Virus (EBV) Infections →
• Lymphoproliferative Disorders — all drugs for Lymphoproliferative Disorders →
• EBV+ Associated Lymphoma — all drugs for EBV+ Associated Lymphoma →
• EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) — all drugs for EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) →

Sponsor

Atara Biotherapeutics — full company profile →

Who can join

Eligibility, any sex, with Epstein-Barr Virus (EBV) Infections or Lymphoproliferative Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral oncogenesis in cancer: from mechanisms to therapeutics.
   Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9
2. Engineering Induced Pluripotent Stem Cells for Cancer Immunotherapy.
   Zhou Y, Li M, Zhou K, Brown J, et al · · 2022 · cited 44× · PMID 35565395 · DOI 10.3390/cancers14092266
3. Recent Advances in Adult Post-Transplant Lymphoproliferative Disorder.
   Markouli M, Ullah F, Omar N, Apostolopoulou A, et al · · 2022 · cited 18× · PMID 36497432 · DOI 10.3390/cancers14235949
4. Epstein-Barr virus-associated post-transplant lymphoproliferative disorders: beyond chemotherapy treatment.
   Shahid S, Prockop SE. · · 2021 · cited 18× · PMID 34485854 · DOI 10.20517/cdr.2021.34
5. Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol.
   Nikiforow S, Whangbo JS, Reshef R, Tsai DE, et al · · 2024 · cited 17× · PMID 38625984 · DOI 10.1182/bloodadvances.2023011626
6. EBV Reactivation and Disease in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients and Its Impact on HSCT Outcomes.
   Law N, Logan C, Taplitz R. · · 2024 · cited 10× · PMID 39205268 · DOI 10.3390/v16081294
7. Joining Efforts for PTLD: Lessons Learned from Comparing the Approach and Treatment Strategies Across the Pediatric and Adult Age Spectra.
   Montanari F, Orjuela-Grimm M. · · 2021 · cited 9× · PMID 33544319 · DOI 10.1007/s11899-021-00606-8
8. Adoptive cell therapy in paediatric extracranial solid tumours: current approaches and future challenges.
   Zappa E, Vitali A, Anders K, Molenaar JJ, et al · · 2023 · cited 7× · PMID 37832507 · DOI 10.1016/j.ejca.2023.113347