tabelecleucel

BIOLOGICAL6 trials

Sponsors

Pierre Fabre Medicament, Atara Biotherapeutics

Conditions

Allogeneic Hematopoietic Cell TransplantEBV+ Associated LymphomaEBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD)EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD)EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)EBV+ Sarcomas

Phase 1

Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)

TerminatedNCT03769467

Atara BiotherapeuticsEpstein-Barr Viraemia, Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC), Epstein-Barr Virus Infections +2

Start: 2019-02-19End: 2021-08-19Updated: 2024-11-14

Phase 2

A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases

Active, not recruitingNCT04554914

Pierre Fabre MedicamentAllogeneic Hematopoietic Cell Transplant, EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD) +8

Start: 2021-07-14End: 2028-05-01Target: 190Updated: 2026-07-31

ATA129-EBV-205 An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases (EBVision)

RecruitingCTIS2024-516623-14-00

Pierre Fabre MedicamentEBV+ associated lymphoproliferative disease in the setting of acquired (non-congenital) immunodeficiency (EBV+ AID LPD), EBV+ associated post-transplant LPD involving the central nervous system (EBV+ CNS PTLD), EBV+ post-transplant LPD where standard first line therapy (rituximab or chemotherapy) is inappropriate +5

Start: 2021-03-17Target: 64Updated: 2025-06-29

Phase 3

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

RecruitingNCT03394365

Pierre Fabre MedicamentAllogeneic Hematopoietic Cell Transplant, Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Lymphoproliferative Disorders +2

Start: 2017-12-29End: 2030-08-01Target: 115Updated: 2026-09-02

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr VirusAssociated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)

Active, not recruitingCTIS2024-516622-57-00

Pierre Fabre MedicamentEpstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease

Start: 2020-05-06Target: 26Updated: 2025-07-14

Unknown Phase

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

Atara BiotherapeuticsEBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Epstein-Barr Viremia +9

Updated: 2023-06-15

Related Papers

Subgroup analysis based on prior treatment from the Phase 3 allele study of tabelecleucel for epstein-barr virus-driven post-transplant lymphoproliferative disease

Blood2025-11-03

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

Blood2024-11-052 citations

Safety of tabelecleucel with pembrolizumab in recurrent/metastatic Epstein–Barr virus-associated nasopharyngeal carcinoma.

Journal of Clinical Oncology2024-06-013 citations

Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol

Blood Advances2024-04-1616 citations

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.

2024-01-3150 citations

Comparative analysis of tabelecleucel and current treatment in patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease following hematopoietic cell transplant or solid organ transplant.

2024-01-013 citations

49O Clinical experience of tabelecleucel in Epistein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) involving the central nervous system

Immuno-Oncology Technology2023-12-011 citations

P1390: NEW AND UPDATED RESULTS FROM A MULTICENTER OPEN-LABEL GLOBAL PHASE3 STUDY OF TAB-CEL FOR EBV+PTLD FOLLOWING HCT OR SOT AFTER FAILURE OF RITUXIMAB OR RITUXIMAB+CHEMOTHERAPY (ALLELE)

HemaSphere2023-08-01

Updated Efficacy and Safety of Tabelecleucel in Patients with Epstein-Barr Virus-Positive (EBV+) Leiomyosarcomas (LMS)

Blood2022-11-153 citations

Exploring the Impact of Humoral Immunogenicity with Tabelecleucel for the Treatment of EBV+ PTLD Following HCT and SOT

Blood2022-11-15

Utilizing TCR-Seq to Detect Tabelecleucel, an Allogeneic Epstein-Barr Virus (EBV)-Specific T-Cell Immunotherapy, Post-Infusion

Blood2022-11-15

Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial.

2022-08-1629 citations

S256: TABELECLEUCEL FOR EBV-DRIVEN POST-TRANSPLANT LYMPHOPROLIFERATIVE DISEASE FOLLOWING ALLOGENEIC HEMATOPOIETIC CELL OR SOLID ORGAN TRANSPLANT AFTER FAILURE OF RITUXIMAB ± CHEMOTHERAPY (ALLELE)

HemaSphere2022-06-012 citations

Demographics and treatment outcomes in patients with EBV<sup>+</sup> PTLD treated with off-the-shelf EBV-specific CTL under an ongoing expanded access program in Europe: First analyses.

Journal of Clinical Oncology2022-06-011 citations

P1457: DEMOGRAPHICS AND TREATMENT OUTCOMES IN PATIENTS WITH EBV+ PTLD TREATED WITH OFF-THE-SHELF EBV-SPECIFIC CTL (TABELECLEUCEL) UNDER AN ONGOING EXPANDED ACCESS PROGRAM IN EUROPE: FIRST ANALYSES

HemaSphere2022-06-01

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 and Chemotherapy (ALLELE)

Blood2021-11-0513 citations

Clinical Outcomes of Solid Organ Transplant Patients with Epstein-Barr Virus-Driven (EBV +) Post-Transplant Lymphoproliferative Disorder (PTLD) Who Fail Rituximab Plus Chemotherapy: A Multinational, Retrospective Chart Review Study

Blood2021-11-0512 citations

Clinical Outcomes of Patients with Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Hematopoietic Stem Cell Transplantation Who Fail Rituximab: A Multinational, Retrospective Chart Review Study

Blood2021-11-056 citations

Overall Survival By Best Overall Response with Tabelecleucel in Patients with Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Solid Organ or Allogeneic Hematopoietic Cell Transplant

Blood2021-11-056 citations

136 ATA3271: An armored, next-generation off-the-shelf, allogeneic, mesothelin-CAR T cell therapy for solid tumors

Regular and Young Investigator Award Abstracts2021-11-011 citations

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