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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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516623-14-00
Acronym
ATA129-EBV-205
Enrollment
64
Registered
2024-10-02
Start date
2021-03-17
Completion date
Unknown
Last updated
2025-06-29

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

Conditions

EBV+ 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, EBV+ primary imunodeficiency lymphoproliferative disease (LPD), EBV+ sarcomas, including CD20-negative disease, including leiomyosarcoma, or smooth muscle tumors

Brief summary

The ORR obtained following administration of tabelecleucel with the first two different human leukocyte antigen (HLA) restrictions

Detailed description

Overall survival (OS), Duration of response (DOR), Progression-free survival (PFS), For EBV-associated lymphoproliferative disease in the setting of primary imunodeficiency (EBV+ PID LPD) cohort:Number of subjects who reach definitive therapy (i.e., allogeneic HCT) for the underlying disease. Time to definitive therapy., For EBV+ sarcoma cohort, including leiomyosarcoma (LMS), or smooth muscle tumors: Clinical benefit rate. ORR by immune response evaluation criteria in solid tumors (iRECIST) criteria [Seymour 2017]

Interventions

Sponsors

Pierre Fabre Medicament
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The ORR obtained following administration of tabelecleucel with the first two different human leukocyte antigen (HLA) restrictions

Secondary

MeasureTime frame
Overall survival (OS), Duration of response (DOR), Progression-free survival (PFS), For EBV-associated lymphoproliferative disease in the setting of primary imunodeficiency (EBV+ PID LPD) cohort:Number of subjects who reach definitive therapy (i.e., allogeneic HCT) for the underlying disease. Time to definitive therapy., For EBV+ sarcoma cohort, including leiomyosarcoma (LMS), or smooth muscle tumors: Clinical benefit rate. ORR by immune response evaluation criteria in solid tumors (iRECIST) criteria [Seymour 2017]

Countries

Austria, Belgium, France, Italy, Spain

Outcome results

None listed

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