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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

ConditionsEpstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)Solid Organ Transplant ComplicationsLymphoproliferative DisordersAllogeneic Hematopoietic Cell TransplantStem Cell Transplant Complications
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPierre Fabre Medicament

About this trial

The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT).

A diagnosis of locally assessed, biopsy-proven EBV+ PTLD.

Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.

Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.

Disqualifiers

Currently active Burkitt, T-cell, NK/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.

Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis.

Untreated CNS PTLD or CNS PTLD for which the participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.

Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • tabelecleucel

    Biological/Vaccine

    Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Treatment groups

115 Participants
are divided into 3 treatment groups
Group A: Cohort SOT-R (C-SOT-R)Experimental treatment 1 intervention
Group B: Cohort SOT-R+C (C-SOT-R+C)Experimental treatment 1 intervention
Group C: Cohort HCT (C-HCT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) in the Analysis Cohorts C-SOT, C-HCT, and Combined Population (C-SOT-R+C, C-SOT-R-Ci, and C-HCT) Who Received Commercial Product, or a Product Manufactured Using a Comparable PV

Time frame
2 years

Secondary outcomes

1

Duration of Response (DOR) in the Analysis Cohorts C-SOT and C-HCT Separately

Time frame
2 years
2

ORR in the Analysis Cohorts C-SOT and C-HCT Combined

Time frame
2 years
3

ORR and DOR in Participants who Received Commercial Product or a Product Manufactured Using a Comparable PV in the Analysis Cohorts C-SOT-R-Ci and C-SOT-R+C Separately and Combined, and in the Analysis Cohort C-HCT

Time frame
2 years
4

DOR in a Combined Population (SOT-R-Ci, SOT-R+C, and HCT) who Received Commercial Product or a Product Manufactured Using a Comparable PV

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pierre Fabre Medicament

Lead sponsor

Source ClinicalTrials.gov
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