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Nanjing Legend Biotech said recently that the FDA has informed the agency that it has suspended the Phase I trial of its autologous CAR-T
therapy LB1901 .
LB1901 is the company's autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL)
FDA CAR-T Lymphoma
So far, only one participant has been dosed, according to Legendary Bio
.
It noted that even before the FDA contacted Legend about the suspension, the company had suspended the trial for "low CD4 + T cell counts in the patient's peripheral blood" and notified the FDA
It noted that even before the FDA contacted Legend about the suspension, the company had suspended the trial for "low CD4 + T cell counts in the patient's peripheral blood" and notified the FDA
Meanwhile, Legend Bio is working with Johnson & Johnson to develop a BCMA-targeting CAR-T therapy, ciltacabtagene autoleucel (cilta-cel)
.
CAR-T cell therapy is a new type of immunotherapy that uses specially transformed T cells to more specifically target cancer cells
.
Doctors first extract T cells from the patient's blood, and then genetically modify these T cells to create special structures of chimeric antigen receptors (CARs) on the surface of the T cell membranes
immunity
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