SAFETY OF EBVALLO IN THE ALLELE STUDY

In the ALLELE study, the safety profile was favourable1,7

Very few treatment-related adverse events 
were reported1,7

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Safety ALLELE

Very few identified and potential risks associated 
with cellular therapies were reported1​​​​​​

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Safety

Data cut-off: November 5th, 2021.

HCT, haematopoietic cell transplantation; SOT, solid organ transplantation; TESAE, treatment-emergent serious adverse event; EBV+, Epstein-Barr virus positive; GvHD, graft-vs-host disease; ICANS, immune effector cell-associated neurotoxicity syndrome; PTLD, post-transplant lymphoproliferative disease; TFR, tumour flare reaction.

SAFETY IN POOLED ANALYSIS (PHASE II & PHASE III)

In a pooled analysis with 103 patients, EBVALLO was well tolerated, with most common adverse reactions occuring in less than a third of patients*2

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Safety

 

 

 

 

ADVERSE REACTIONSN (%)GRADEOUTCOME
TFR1 (1%)3Patient recovered from TFR
GvHD5 (4,9%)

2 grade 1

1 grade 2

1 grade 3

1 grade 4

No fatal events were reported.

4 patients recovered from GvHD

*ALLELE TRIAL N=43 and EBVCTL 201 N=60.      
‘EBV-CTL-201 is a Phase 2 trial with patients treated with EBVALLO: multicentre, open-label study for treatment of EBV viremia or EBV-driven malignancies for whom there are no appropriate alternative therapies10.      
ALT, alanine transaminase; AST, aspartate aminotransferase; EBV+, Epstein-Barr virus positive; GvHD, post-transplant lymphoproliferative disease; TFR, tumour flare reaction; WBC, white blood cell. 

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