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CD19 CAR-T Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL): The First Experience of investigator-initiated Trials with CAR-T Manufacturing at point of care.
Abstract No. : 35

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Engineered T cell therapy (e.g., CAR/TCR-T)
CD19 CAR-T cell therapy has emerged as an innovative approach for the treatment of acute lymphoblastic leukemia (ALL); however, domestic clinical research in this field remains limited. This study marks the first instance in a domestic hospital where CD19 CAR-T cells were produced and administered to patients (NCT05210907). To enhance therapeutic efficacy and accessibility, automated closed systems like Prodigy were introduced for manufacturing under Good Manufacturing Practice (GMP) conditions. Additionally, without undergoing cryopreservation, cells were directly administered at doses of 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight for patients under 50 kilograms, and 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) for those over 50 kilograms. Results from seven patients demonstrated successful outcomes in five or more, with the remaining two experiencing CD19-negative relapse. SNUH-CD19-CAR-T has been recognized for its potent anti-tumor activity in ALL treatment. These findings are expected to expand future clinical research and therapeutic development efforts.
#CAR(Chimeric antigen receptor)-T cell
#Investigator Initiated Trials(IITs
#Acute lymphoblastic leukemia (ALL)
#cell therapy manufacturing
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