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UCART22 is an allogeneic, off-the-shelf chimeric antigen receptor (CAR) T-cell therapy developed for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). The therapy consists of donor-derived T-cells that are genetically engineered to express a CAR targeting CD22, a surface antigen commonly found on B-cell malignancies. By targeting CD22, these modified T-cells are designed to recognize and kill malignant B-cells. UCART22 is being evaluated in clinical trials (notably the BALLI-01 study) and has received Orphan Drug Designation and Rare Pediatric Disease Designation from regulatory agencies in both the United States and European Union[2][3][4][5][6]. Cellectis has developed proprietary manufacturing capabilities for this product, allowing fully in-house production[6][8].
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