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Updated: Feb 17, 2026
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Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography
Published on: February 17, 2022
Puzolcabtagene Autoleucel: Pediatric First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.
Abstract:
Puzolcabtagene autoleucel [®] is an autologous, humanized anti-CD19 chimeric antigen receptor (CAR) T-cell therapy developed by Chongqing Precision Biotech for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), B-cell leukemias and lymphomas, and non-Hodgkin lymphoma. CAR T-cell therapy is a personalized immunotherapy in which a patient's own T cells are genetically engineered to recognize and eliminate malignant cells through direct cytotoxicity, induction of apoptosis, and TNF ligand-mediated signaling pathways. To reduce immunogenicity, puzolcabtagene autoleucel incorporates a humanized CD19-specific single-chain variable fragment. On 4 November 2025, puzolcabtagene autoleucel received its first approval in China for the treatment of CD19+ relapsed or refractory (R/R) B-ALL in patients aged 3-21 years. This article summarizes the key developmental milestones leading to this first approval.
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