Shanghai Cellular Therapy Group Achieves Complete Remission in First Patient Treated with 6-Hour Ultra-Rapid Trispecific CAR-T Therapy
Shanghai Cell Therapy Group
Cell Health Medical Products and Service Provider
December 28, 2024
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December 21, 2024, in China's pharmaceutical quality managementAt the 4th Academic Symposium hosted by the Cell Therapy Quality Control and Research Professional Committee of the Management Association, the Group Chairman and CEO, Professor Qijun Qian, publicly disclosed the results for the first time. The case involved a patient with relapsed and refractory DLBCL who had previously failed three lines of treatment and showed no response to the most recent R-COMP regimen. The patient received CD19/CD22/BCMA triple-target CAR-T therapy with a production time of 6 hours and a dose of 5×10E4 CAR-T/kg (1/40 of the standard dose).Achieved CR at the first evaluation after 28 days, with no significant side effects.
In addition, the patient's CAR-T cells significantly proliferated in vivo, and the peripheral blood CAR-T positive rate reached80.9%, the absolute count of CAR-T cells reached2315 cells/µL, is the traditional process CAR-TMore than 10 times。
▲ First Case of Complete Remission: Clinical Study Data
The press release pointed out that this isShanghai Cell Therapy GroupFollowing the breakthrough of 30-hour rapid preparation, this is another significant reduction in time—cutting the traditional production cycle of approximately 10 days down to just 6 hours. Notably, the FlashCAR platform process, with its 30-hour production and a dose of 5×10E4 CAR-T/kg (1/40 of the conventional dose), has treated three patients with relapsed/refractory diffuse large B-cell lymphoma using CD19/CD22/BCMA triple-targeted CAR-T therapy.Two cases achieved complete remission, and one case showed tumor reduction of more than 90%.。
Currently marketed CAR-T products all utilize lentiviral or retroviral vectors, with highly mature production processes. To achieve curative efficacy, low cost, and on-demand availability of CAR-T cell therapies, there is an urgent need to develop novel, efficient, safe, and low-toxicity gene-writing systems, along with the independent intellectual property rights for self-developed technologies in China.
Shanghai Cell Therapy Group relies on its self-developed JL Gene Writing System and VHHMAb.®The 4th generation nanobody discovery platform and LNP delivery system have established the Flash CAR-T cell preparation platform. The application of these innovative technologies provides a solid foundation for achieving highly effective, low-cost, and instant CAR-T therapy.
Based on technological innovation and process upgrading,The world's firstNanobody Flash CAR-T Covering Three Targets of Whole B Cells and Tumor Microenvironment-Dependent Nanobody Flash CAR-T with Autocrine PD1 Antibody Enter IIT Clinical Research, Achieving Complete Remission in Multiple Patients. In Addition, asWorld's First Nano-Antibody Armored CAR-TBZDS1901 is currently undergoing Phase I/II clinical trials and has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA).
References:
1. Official WeChat Account of the Company
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