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SHB-02-CD19 is an autologous, point-of-care chimeric antigen receptor (CAR) T-cell therapy developed by Sheba Medical Center for the treatment of relapsed or refractory B-cell malignancies, including acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). The therapy is manufactured in-house at Sheba's Advanced Biotherapy Center using a gammaretroviral vector to engineer a patient's T cells to express a CAR construct. This construct features a mouse-derived FMC63 single-chain variable fragment (scFv) targeting the CD19 antigen, fused to a human CD28 costimulatory domain and a CD3-zeta signaling domain. A key feature of SHB-02-CD19 is its rapid point-of-care manufacturing process, which achieves a turnaround time of approximately 10-11 days from apheresis to infusion. It is currently being evaluated in Phase I/II clinical trials for both pediatric and adult populations.
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