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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516622-57-00

Acronym

ATA129-EBV-302

Enrollment

Registered

2024-09-27

Start date

2020-05-06

Completion date

Unknown

Last updated

2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease

Brief summary

ORR (CR or PR) obtained following administration of tabelecleucel with up to 2 different HLA restrictions in each of the following analysis cohorts: • SOT • HCT • A combined population (SOT-R-Ci, SOT-R+C, and HCT) following administration of commercial product or a product manufactured using a comparable PV

Detailed description

DOR in the SOT and HCT cohorts separately., ORR and DOR in SOT and HCT cohorts combined., ORR and DOR in subjects who received commercial product or a product manufactured using a comparable PV in the following: SOT-R-Ci and SOT-R+C combined, and separately, HCT, 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, Rates of CR and PR, Time to response and time to best response, OS, Rates of allograft loss/rejection episodes (for SOT cohort only)

Interventions

DRUGEbvallo 2.8 × 10^7 – 7.3 × 10^7 cells/mL dispersion for injection

DRUGtabelecleucel

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR (CR or PR) obtained following administration of tabelecleucel with up to 2 different HLA restrictions in each of the following analysis cohorts: • SOT • HCT • A combined population (SOT-R-Ci, SOT-R+C, and HCT) following administration of commercial product or a product manufactured using a comparable PV	—

Secondary

Measure	Time frame
DOR in the SOT and HCT cohorts separately., ORR and DOR in SOT and HCT cohorts combined., ORR and DOR in subjects who received commercial product or a product manufactured using a comparable PV in the following: SOT-R-Ci and SOT-R+C combined, and separately, HCT, 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, Rates of CR and PR, Time to response and time to best response, OS, Rates of allograft loss/rejection episodes (for SOT cohort only)	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026