FDA Grants Clearance to Novel Car T Therapy KITE-363 for Treatment of Patients With LBCL

By Cameron Kelsall, MD /alert Contributor
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An Investigational New Drug application for KITE-363, a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD20, has been cleared by the US Food and Drug Administration (FDA), according to a press release issued by Kite Pharma, the drug’s manufacturer.

Following FDA clearance, Kite Pharma intends to open a phase 1 study of KITE-363 in patients with large B-cell lymphoma by the end of 2021. 

According to the press release, KITE-363 is the first CAR T-cell therapy manufactured by the company that targeted multiple antigens. In preclinical studies, the agent showed strong antigen-specific activity against both CD19 and CD20 targets.

Each year, approximately 22,000 patients in the United States are diagnosed with large B-cell lymphoma, an aggressive non-Hodgkin lymphoma subtype. There exists a large unmet need for novel therapies to treat patients who relapse or develop refractory disease following first-line treatment.

“CD19-directed CAR T-cell therapies have transformed outcomes for patients with relapsed or refractory large B-cell lymphomas, and we are excited to continue our research on the next generation of potential cell therapy advances for patients,” Francesco Marincola, MD, senior vice president and global head of cell therapy research at Kite, said in the press release. “KITE-363, which targets two antigens highly expressed in large B-cell lymphomas — CD19 and CD20 — is the next step forward in our research that may improve current treatments to help more patients.”


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