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4SCAR19U is an "off-the-shelf" universal chimeric antigen receptor (CAR) T-cell therapy targeting CD19-positive B-cell malignancies. Developed by the Shenzhen Geno-immune Medical Institute, it belongs to the 4SCAR series of fourth-generation CAR-T products. The therapy utilizes T cells from healthy donors that are genetically engineered to express a CAR construct containing CD28 and 4-1BB costimulatory domains, the CD3ζ signaling chain, and an inducible caspase 9 (iCasp9) safety switch. The "U" designation indicates its status as a universal product, allowing for bulk manufacturing and immediate clinical availability without the need for patient-specific (autologous) cell collection and processing. This approach is intended to overcome the long preparation times, high costs, and functional defects often associated with autologous T cells in heavily pretreated patients.
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