How Effective is Off-the-Shelf T-cell Therapy Tab-cel for EBV+ PTLD?

Did you develop diffuse large B-cell lymphoma (DLBCL) after receiving an organ or allogeneic stem cell transplant? This is a rare condition referred to as PTLD, post-transplant lymphoproliferative disorders. 

Learn how an off-the-shelf T-cell therapy called tabelecleucel/tab-cel (Ebvallo, Atara Biotherapeutics) is supporting patients in a clinical trial whose DLBCL developed from Epstein-Barr virus (EBV) positive PTLD and how you may be eligible to join the study to receive tab-cel. 

What Causes PTLD?

Before we discuss the results of the study, below you’ll learn what causes PTLD. 

Post-transplant lymphoproliferative disorder (PTLD) affects up to 10% of stem cell or organ transplant recipients, developing when the Epstein-Barr virus (EBV) exploits their compromised immune systems. The conditioning chemotherapy for transplants, aimed at eradicating cancer cells, significantly weakens the immune system—especially T-cells that control EBV-infected B-cells—while ongoing immunosuppression to prevent rejection increases susceptibility to EBV and potentially other viruses that can trigger PTLD later on.

If patients develop PTLD, initial treatment typically involves rituximab combined with chemotherapy. Should this approach fail or if the cancer returns (relapsed/refractory), further treatment is necessary due to generally low survival rates. Tab-cel offers an alternative therapy option in these cases, potentially enhancing survival outcomes for patients who respond well to the treatment. 

A New T-cell Therapy is Supporting Patients with PTLD

Tab-cel, an "off-the-shelf" therapy consisting of unmodified donor T-cells targeting EBV-infected cancer cells, offers immediate availability compared to the weeks required to prepare personalized CAR T-cell therapies. 

Approved in Europe since 2022 for EBV+ PTLD, its FDA approval in the U.S. is pending as third-party manufacturer compliance issues are managed. 

Tab-cel's effectiveness continues to be evaluated through the ALLELE trial. Armin Ghobadi, MD, from Washington University School of Medicine, presented phase 3 updates at the 2024 ASH conference. The study involved 75 patients with relapsed/refractory EBV+ PTLD—primarily DLBCL—who received an average of six tab-cel infusions over two months. 

Post-treatment, 50.7% of these patients saw a partial or complete reduction in cancer cells, with 28% achieving complete remission. Notably, those who responded maintained remission for an average of 23 months, significantly extending the typical four-month survival outcome for untreated cases.

Importantly, the researchers found no side effects reported were related to tab-cel inluding graft-vs-host disease or organ rejection, despite tab-cel’s donor-derived nature. 

How You Can Receive Tab-cel

These findings underscore tab-cel's potential as a new treatment option for individuals with relapsed/refractory EBV+ PTLD. For those interested in participating in the ALLELE study, click here to review your eligibility. The international trial is recruiting patients in over 70 hospitals. 

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Sources: 

• Updated Clinical Results: A Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Recipients with Epstein–Barr Virus-Driven Post Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab Plus Chemotherapy
• 628. Aggressive Lymphomas: Cellular Therapies: Novel Strategies for Cell Therapies in Aggressive Lymphomas
• Tabelecleucel BLA Receives FDA CRL in Pretreated EBV+ Post-Transplant Lymphoproliferative Disease
• Post-Transplant Lymphoproliferative Disorders (PTLD)