Tab-cel (tabelecleucel) / Atara, Pierre Fabre - LARVOL DELTA

Recognition and management of early complications in CAR-T cell therapy and virus-specific T-lymphocyte therapy: a practical clinical reference. (PubMed, Front Immunol) - "Eight products are currently authorized by the European Medicines Agency, encompassing seven autologous CAR-T products targeting CD19 or BCMA and tabelecleucel (Ebvallo), the first approved allogeneic off-the-shelf EBV-specific T-cell product for EBV-positive post-transplant lymphoproliferative disease...CRS is graded by ASTCT consensus criteria and managed with tocilizumab as first-line pharmacological therapy; steroid-refractory ICANS is most commonly treated with high-dose intravenous anakinra (up to 12 mg/kg/day) which is currently the most studied second-line option, although the supporting evidence remains largely observational...Prompt recognition, early pharmacological intervention, and monitoring are essential to minimize non-relapse mortality. Expanding real-world experience and the integration of pre-treatment risk stratification tools will continue to refine evidence-based practice in this rapidly evolving field, ultimately leading to improved patient..."

Journal • Review • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Neutropenia • Oncology • Pediatrics • Transplantation

Multicenter, Open-Label, Phase 3 (P3) Study of Tabelecleucel (Tab-cel) for Solid Organ (SOT) or Allogeneic Hematopoietic Cell Transplant (HCT) Recipients with Epstein–Barr Virus-Driven Post Transplant Lymphoproliferative Disease (EBV+ PTLD) after Failure of Rituximab (R) or Rituximab and Chemotherapy (R + C) (ALLELE) (TCT-ASTCT-CIBMTR 2022) - P3 | "Conclusions : Tab-cel P3 interim data show clinically meaningful outcomes and promising ORR and OS in a pt population with poor survival and no approved therapies. Tab-cel was well tolerated without evidence of safety concerns typically observed with autologous chimeric antigen receptor cell therapies."

Clinical • IO biomarker • P3 data • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Inflammation • Oncology • Rare Diseases • Transplantation

New and Updated Results from a Multicenter, Open-Label, Global Phase 3 (P3) Study of Tabelecleucel (Tab-cel) for Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT) or Solid Organ Transplant (SOT) after Failure of Rituximab (R) or Rituximab and Chemotherapy (R+CT) (ALLELE) (TCT-ASTCT-CIBMTR 2023) - P3 | "No fatal TEAEs, GvHD or organ rejection were reported as tab-cel related. Conclusions : Updated ALLELE P3 data, which included additional pts and longer follow-up, confirm that tab-cel provides consistent clinically meaningful outcomes, including improved overall ORR, prolonged DOR and OS, and no safety concerns seen with other adoptive T-cell therapies, making it a potentially transformative treatment advance for r/r EBV + PTLD."

Clinical • IO biomarker • P3 data • Post-transplantation • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Solid Organ Transplantation • Transplantation

Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial. (PubMed, Lancet Oncol) - P3 | "Tabelecleucel provides clinical benefit in patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease, for whom there are no other approved therapies, without evidence of safety concerns seen with other adoptive T-cell therapies. These data represent a potentially transformative and accessible treatment advance for patients with relapsed or refractory disease with few treatment options."

IO biomarker • Journal • P3 data • Post-transplantation • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Oncology • Rare Diseases • Solid Organ Transplantation • Transplantation

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 (ASH 2024) - P3 | "The safety profile remains consistent with previous findings. These results represent a potential new treatment paradigm for pts with R/R EBV+ PTLD."

Clinical • P3 data • Post-transplantation • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Solid Organ Transplantation • Transplantation

Overall and Progression-Free Survival in Patients With Epstein-Barr Virus–Driven Posttransplant Lymphoproliferative Disease Following Tabelecleucel Treatment: Results From the Phase 3 ALLELE Trial (SOHO 2026) - P3 | "Updated results demonstrate clinical benefit and safety of tabelecleucel in patients with R/R EBV+ PTLD, a population with poor survival. CI: confidence interval, HCT: hematopoietic cell transplant, NE: not estimable, ORR: objective response rate, OS: overall survival, PFS: progression-free survival, R/R EBV+ PTLD: relapsed/refractory Epstein-Barr virus–positive posttransplant lymphoproliferative disease, SOT: solid organ transplant, TEAEs: treatment-related treatment-emergent adverse events."

Clinical • P3 data • Post-transplantation • Oncology

Post-transplant lymphoproliferative disorder after solid organ transplantation: a comprehensive review. (PubMed, Front Transplant) - "Management follows a sequential strategy: immunosuppression reduction (ISR) as the mainstay first step, followed by rituximab, then chemoimmunotherapy (R-CHOP) for refractory or high-risk disease, with PET/CT-based response assessment using Lugano criteria at each decision point. Tabelecleucel, an allogeneic EBV-specific cytotoxic T-lymphocyte (CTL) product, represents the first approved cellular therapy for refractory EBV-positive PTLD. Immune checkpoint inhibitors carry unacceptably high organ rejection rates and are not recommended for standard PTLD management. Key unmet needs include standardizing EBV surveillance thresholds for preemptive intervention, biomarker-driven risk stratification (PD-L1, LMP1, tumor EBV viral load), and prospective multicenter data on novel immunotherapy combinations in immunosuppressed transplant recipients."

IO biomarker • Journal • Review • B Cell Lymphoma • Bone Marrow Transplantation • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Organ Transplantation • Transplantation • PD-L1 • TP53

Case Report: Hyperinflammatory toxicities after Epstein-Barr virus-associated post-transplant lymphoproliferative disorder and hemophagocytic lymphohistiocytosis in a pediatric kidney transplant recipient. (PubMed, Front Immunol) - "Despite etoposide- and steroid-based HLH therapy, IVIG, anakinra, and a maternal virus-specific T-cell infusion, he showed recurrent hyperinflammation. After a single dose of the allogeneic EBV-specific T-cell product tabelecleucel (Ebvallo) and exacerbation of HLH, he experienced cytokine release syndrome and neurotoxicity with acute liver failure, coagulopathy, and renal failure. He died from refractory lactic acidosis and multiorgan failure. This case highlights the therapeutic complexity of EBV-HLH in a solid-organ transplant recipient and underscores both the rationale for and risks of cellular immunotherapy amid severe hyperinflammation and organ dysfunction."

Journal • Epstein-Barr Virus Infections • Glomerulonephritis • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Hepatology • Immunology • Inflammation • Liver Failure • Metabolic Disorders • Nephrology • Pediatrics • Rare Diseases • Renal Disease • Solid Organ Transplantation • Transplantation

CAR T-CELL THERAPY FOR POST-TRANSPLANT LYMPHOPROLIFERATIVE DISEASE, A REAL-WORLD ANALYSIS ON BEHALF OF THE EBMT LYMPHOMA WORKING PARTY (EHA 2026) - "PTLD management relies on reduction of immunosuppressive therapy when feasible, administration of rituximab with or without chemotherapy and, more recently, treatment with tabelecleucel in EBV positive cases. Figure 1 - Overall Survival courbe for patients with post-transplant lymphoproliferative disease after CAR T-cells administration. PTLD- Post-transplant lymphoproliferative disease, FL - follow-up"

CAR T-Cell Therapy • Clinical • Post-transplantation • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Solid Organ Transplantation

TABELECLEUCEL FOR ALLOGENEIC OR SOLID ORGAN TRANSPLANT RECIPIENTS WITH EBV+ PTLD AFTER FAILURE OF RITUXIMAB OR RITUXIMAB PLUS CHEMOTHERAPY: PAEDIATRIC SUBGROUP ANALYSIS OF THE PHASE 3 ALLELE STUDY (EHA 2026) - "Summary/Conclusion This analysis of 12 paediatric patients from the ALLELE trial suggests that the risk/benefit profile in the paediatric subgroup is consistent with that reported in the overall population. These findings support the use of tabelecleucel in paediatric patients with refractory/relapsed EBV+ PTLD who have poor survival and limited treatment options."

Clinical • P3 data • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Pediatrics • Solid Organ Transplantation • Transplant Rejection • Transplantation

RELAPSED OR REFRACTORY (R/R) EBV-RELATED POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDERS (PTLD): REAL-LIFE MULTICENTER ITALIAN EXPERIENCE WITH TABELECLEUCEL (EHA 2026) - "Eighteen patients (78.3%) received rituximab monotherapy as first-line treatment, one patient benefited from immunoreduction alone as a first-line approach. Longer follow-up and larger cohorts are needed to better define outcomes, particularly in HSCT recipients. Additional studies are warranted to define prognostic factors influencing response to tabelecleucel."

Clinical • IO biomarker • Post-transplantation • B Cell Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Solid Organ Transplantation

Tabelecleucel for Epstein-Barr Virus-Driven Posttransplant Lymphoproliferative Disease (EBV+ PTLD) After Treatment Failure in the Phase 3 ALLELE Trial (ATC 2026) - P3 | "We report subgroup analyses based on prior treatment.* HCT recipients who failed rituximab treatment and SOT recipients who failed rituximab +/- chemotherapy (SOT-RC or SOT-R) received intravenous tabelecleucel (2x106 cells/kg) on days 1, 8, and 15 in 35-day cycles. These results confirm the efficacy of tabelecleucel, with ORRs of 48% in HCT and 47% in SOT recipients with R/R EBV+ PTLD. The ORR was favorable in SOT-R compared with SOT-RC."

P3 data • Post-transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Solid Organ Transplantation • Transplantation

OVERALL AND PROGRESSION-FREE SURVIVAL IN PATIENTS WITH EPSTEIN-BARR VIRUS-DRIVEN POST-TRANSPLANT LYMPHOPROLIFERATIVE DISEASE (EBV+ PTLD) TREATED WITH TABELECLEUCEL IN THE PHASE 3 ALLELE TRIAL (EHA 2026) - P3 | "Summary/Conclusion Results from ALLELE show OS and PFS benefit with tabelecleucel in patients with R/R EBV+ PTLD, who otherwise have a poor probability of survival. ORR and safety data are consistent with previous reports, supporting tabelecleucel as a novel treatment option for R/R EBV+ PTLD."

Clinical • P3 data • Post-transplantation • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Solid Organ Transplantation • Transplant Rejection • Transplantation

Ladder Logic: Winning moves in the PTLD journey with EBVALLO® (EHA 2026) - "Sponsored by LABORATOIRES Pierre Fabre"

Welcome and EBVALLO® clinical evidence (EHA 2026) - "Sponsored by LABORATOIRES Pierre Fabre"

Clinical

Real-world experience with tabelecleucel. (PubMed, Blood Adv) - No abstract available

Journal • Real-world evidence

Pierre Fabre Pharmaceuticals Announces Regulatory Update Following Type A Meeting with U.S. Food and Drug Administration (FDA) on Tabelecleucel Biologic License Application (BLA) (PRNewswire) - "During the meeting, the FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a marketing application of tabelecleucel for the proposed indication. As a part of the resubmission plan being defined with the FDA, PFP will submit an updated dataset with additional patients and longer follow up from the pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with R/R EBV+ PTLD following solid organ transplant or hematopoietic cell transplant as well as supportive data."

FDA filing • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Tabelecleucel for EBV+ PTLD in Pediatric Patients After Rituximab +/− Chemotherapy Failure (ASPHO 2026) - "This analysis of 12 pediatric patients from the ALLELE trial is consistent with the overall population, with an ORR of 50% and 5/6 treatment responders still alive at data cutoff. These results support the clinical benefit of tabelecleucel in pediatric patients with R/R EBV+ PTLD who have limited treatment options and typically poor survival."

Clinical • Epstein-Barr Virus Infections • Pediatrics • Solid Organ Transplantation

EBVision: A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases (clinicaltrials.gov) - P2 | N=190 | Active, not recruiting | Sponsor: Pierre Fabre Medicament | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Epstein-Barr Virus Infections • Immunology • Leiomyosarcoma • Oncology • Primary Immunodeficiency • Sarcoma • Solid Organ Transplantation • Solid Tumor • Transplantation

The immunosuppressive tumor microenvironment in post-transplant lymphoproliferative disorder: pathogenesis and novel therapeutic frontiers. (PubMed, Front Immunol) - "These viral strategies are contrasted with the distinct pathogenesis of late-onset, EBV-negative PTLD, which relies on genomic instability rather than viral immunomodulation. Finally, we evaluate how this deepened understanding of the TME is transforming therapeutic paradigms, moving from standard reduction of immunosuppression toward targeted interventions, such as EBV-specific adoptive T-cell therapies (Tabelecleucel) and CAR-T cells, designed to dismantle the tumor's protective architecture while minimizing the high risk of allograft rejection associated with checkpoint inhibitors."

Biomarker • Journal • Review • Epstein-Barr Virus Infections • Immunology • Oncology • Transplant Rejection • Transplantation

Chaudhury S, Reshef R, Nikiforow S, et al. Subgroup analysis in pediatric patients from the phase 3 study of tabelecleucel for allogeneic or solid organ transplant recipients with Epstein-Barr virus-driven post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE). Blood. 2025;146(suppl 1):5488. (PubMed, Blood) - No abstract available

Journal • P3 data • Epstein-Barr Virus Infections • Pediatrics • Solid Organ Transplantation • Transplantation

Nikiforow S, Mahadeo K, Chaganti S, et al. Subgroup analysis based on prior treatment from the phase 3 allele study of tabelecleucel for epstein-barr virus-driven post-transplant lymphoproliferative disease [abstract]. Blood. 2025;146(suppl 1):1934. (PubMed, Blood) - No abstract available

Journal • P3 data • Epstein-Barr Virus Infections • Transplantation

REAL-WORLD EXPERIENCE WITH TABELECLEUCEL (EBMT 2026) - "Background: Tabelecleucel (Tab-cel) is an allogeneic Epstein–Barr virus (EBV)-specific T-cell therapy approved in the European Union for relapsed or refractory (R/R) EBV-associated post-transplant lymphoproliferative disorder (PTLD) after failure of rituximab or immunochemotherapy. Tab-cel demonstrates meaningful efficacy with a favorable safety profile in R/R PTLD/LPD within this highly vulnerable population of immunodeficient or transplanted patients. However, the durability of response depends on re-establishing effective immunosurveillance, and Tab-cel alone was not consistently sufficient to maintain long-term disease control. Future approaches should clarify how best to integrate Tab-cel into the therapeutic pathway for R/R LPD, potentially including optimized HLA matching to enhance antiviral activity and consideration of consolidation strategies following Tab-cel therapy."

Clinical • Real-world • Real-world evidence • Epstein-Barr Virus Infections • Solid Organ Transplantation

RELAPSED OR REFRACTORY POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDERS: REAL-LIFE MULTICENTER ITALIAN EXPERIENCE WITH TABELECLEUCEL (EBMT 2026) - "Sixteen patients (84.2%) received rituximab monotherapy as first line treatment. The preliminary Italian experience supports the efficacy and safety of tabelecleucel, consistent with the results of the ALLELE trial in SOT. In our cohort no response to tabelecleucel was observed in PTLD after HSCT, remarkably 3 of these patients did not meet ALLELE inclusion criteria. It is essential to identify early potential candidates for this promising new therapy, which is now readily accessible in our country."

Clinical • IO biomarker • Post-transplantation • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

REAL-WORLD EXPERIENCE WITH TABELECLEUCEL (EBMT 2026) - "Background: Tabelecleucel (Tab-cel) is an allogeneic Epstein–Barr virus (EBV)-specific T-cell therapy approved in the European Union for relapsed or refractory (R/R) EBV-associated post-transplant lymphoproliferative disorder (PTLD) after failure of rituximab or immunochemotherapy. Tab-cel demonstrates meaningful efficacy with a favorable safety profile in R/R PTLD/LPD within this highly vulnerable population of immunodeficient or transplanted patients. However, the durability of response depends on re-establishing effective immunosurveillance, and Tab-cel alone was not consistently sufficient to maintain long-term disease control. Future approaches should clarify how best to integrate Tab-cel into the therapeutic pathway for R/R LPD, potentially including optimized HLA matching to enhance antiviral activity and consideration of consolidation strategies following Tab-cel therapy."

Clinical • Real-world • Real-world evidence • Epstein-Barr Virus Infections • Solid Organ Transplantation