Key points are not available for this paper at this time.
The first and second authors contributed equally to this publication. Background: Tisagenlecleucel is a CD19-directed autologous chimeric antigen receptor (CAR)-T cell therapy approved for the treatment of patients (pts) up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory or in ≥ 2nd relapse. However, pts 1 day of leukapheresis to meet acceptance criteria. Conclusions: Leukapheresis and tisagenlecleucel manufacturing in pts with r/r ALL < 3 years of age and low weight (as low as 6 kg and as young as 3 months) are feasible and do not present manufacturability risk compared to Novartis clinical trial experience in patients ≥ 3 years of age. Table Disclosures Eldjerou: Novartis Pharmaceuticals Corporation: Employment. Acker:Novartis: Employment. Howick:Novartis: Employment. Clough:Novartis: Employment. Fuchs:Novartis: Employment. Salmon:Novartis: Employment. Willert:Novartis: Employment. Tiwari:Novartis: Employment. Pujols:Novartis: Employment. Robson:Novartis: Employment.
Eldjerou et al. (Wed,) studied this question.