Novartis Enrolls First Chinese Patient in Global Phase 3 BELINDA Trial of CAR-T Therapy Kymriah (Tisagenlecleucel)

On October 30, Novartis announced that its breakthrough CAR-T therapy CTL019 (tisagenlecleucel, Kymriah) had successfully enrolled the first Chinese participant in September 2020, following its approval for clinical trials in China last year. According to public information, Kymriah is a CD19 chimeric antigen receptor T-cell (CAR-T) immunotherapy and the first CAR-T therapy approved globally.

Tisagenlecleucel was jointly developed by researchers at the University of Pennsylvania and Novartis, with commercialization and promotion handled by Novartis. The drug was granted Breakthrough Therapy Designation, Priority Review, and Fast Track Designation by the U.S. Food and Drug Administration (FDA). In August 2017, the FDA approved tisagenlecleucel for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse, making it the first CAR-T therapy ever approved in human history. In May 2018, the FDA further approved tisagenlecleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).

According to the press release, the first Chinese participant has been enrolled in Belinda, a global, multicenter, randomized, open-label Phase 3 clinical trial that is part of Novartis’ global tisagenlecleucel clinical development program. The study aims to evaluate the efficacy, safety, and tolerability of tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma who have failed first-line immunochemotherapy containing anti-CD20 monoclonal antibodies and anthracyclines.

CAR-T therapy is a personalized treatment that involves collecting and isolating T cells from the patient’s peripheral blood, followed by genetic modification at a manufacturing facility to equip them with the necessary instructions to express chimeric antigen receptors (CARs) on their cell surface. The genetically modified T cells are then expanded at the manufacturing center. The newly generated CAR-T cells are infused back into the patient, where they recognize and eliminate specific tumor cells.

References:

[1] Novartis’ Advanced CAR-T Therapy Introduced to China, Collaborating with Various Parties to Actively Advance Clinical Research. Retrieved Oct 30, 2020, from https://mp.weixin.qq.com/s/PmkZ1GnQpJIARsplRclTTw

[2] Novartis Official Website and Public Press Releases

Note: The original text has been abridged.

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