On February 23, the phase II registration clinical trial of the CAR-T cell product pCAR-19B cell autologous infusion preparation which independently developed by Chongqing Precision Biotech Co., Ltd. (hereinafter referred to as Chongqing Precision) was conducted in Beijing Children's Hospital Affiliated to Capital Medical University (hereinafter referred to as Beijing Children's Hospital) was officially launched. The center is headed by Professor Wang Tianyou (Principal Investigator, PI), Chairman of the Pediatric Branch of the Chinese Medical Association and Chief Physician of Beijing Children's Hospital, and Professor Zhang Ruidong, Chief Physician of the First Department of Hematology of Beijing Children's Hospital, served as the Executive Investigator (Sub-investigator, Sub-I). The product will be used to treat children and adolescents with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).

At the meeting, the principal investigator, Professor Wang Tianyou, and Professor Qian Cheng, the chief scientist of Chongqing Precision, delivered speeches successively, hoping that all parties will work together to complete the clinical trial with high quality and efficiency, so that more patients can benefit from this therapeutic product in the future. Afterwards, Song Lijuan from the Beijing Children's Hospital Institutional Office and clinical supervisors conducted GCP and project-related training for the project team members. Experts discussed lively and made positive speeches, and made valuable suggestions for the development of the project. At the end of the meeting, Professor Wang Tianyou announced the official launch of the project and called on experts to actively promote it to benefit more patients.

PCAR-19B cell autologous preparation is a Class I biological new drug independently developed by Chongqing Precision Biotech Co., Ltd., and obtained the implied clinical license for B-ALL indications for children and adolescents in February, 2019. It is the first CAR-T product in China to enter phase II clinical registration for this indication, and the first CAR-T product with humanized design for this indication in China. Up to now, this product has been approved for three indications: children and adolescents with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin's lymphoma (B-NHL). 

The clinical trial data of phase I registration of this product showed that all 9 patients in the group got complete remission (CR), the overall remission rate reached 100%, and the minimal residual disease (MRD) of the patients who reached complete remission (CR) for the first time was negative. No dose-limiting toxicity (DLT) and treatment-related deaths occurred, and the overall safety and tolerance were good. Phase II registered clinical trial of pCAR-19B product is a multi-center clinical trial, which will recruit clinical trial patients in hematology departments of more than 10 top-three hospitals in China, aiming at evaluating the efficacy and safety of pCAR-19B in the treatment of children and adolescents with relapsed/refractory leukemia.