2023-09-27
Recentently,"Mr. Sun" (pseudonym), the patient of the world's first "clinical trial of PD1 knockout non-viral site-specific integrated CD19-CART cells for the treatment of relapsed and refractory non-Hodgkin's lymphoma", has lived without cancer for more than 3 years!
The clinical trial above was launched by BRL Medicine and the First Affiliated Hospital of Zhejiang University School of Medicine. It is worth mentioning that the CAR-T treatment product that Mr. Sun received is the PD1 knockout non-viral site-specific integrated CD19-CART product (Pipeline code: "BRL-201") developed by BRL Medicine based on its non-viral site-specific integrated CAR-T platform (Quikin CART®).It is also the world's first autologous CAR-T cell product that achieves targeted integration of the genome at the PD1 site and knocks out the PD1 gene without using viral vectors. The research results were published in the top international journal Nature on August 31, 2022 , and were rated as "Top Ten Research Progress in Hematology in China in 2022" and "Important Medical Progress in China in 2022".
Recent photos of "Mr. Sun"'. After receiving BRL-201 CAR-T treatment, he has completely recovered to a healthy state. He regularly exercises and travels, and enjoys a normal life.
Seeing that patients can get treatment and recover and go home, Dr. Huang He, the principal investigator (PI) of this clinical study, said: "Non-Hodgkin's lymphoma is a hematological malignant tumor originating in lymphoid tissue, accounting for all 80%-90% of lymphomas. Although patients achieve remission after initial treatment, they often relapse later. Although CAR-T products have been approved for the clinical treatment of relapsed and refractory non-Hodgkin lymphoma, The overall efficacy is still limited. Through the results of this clinical study, BRL Medicine’s non-viral targeted integrated CAR-T products have demonstrated excellent safety and effectiveness in clinical treatment. The first patient, Mr. Sun, was hospitalized only 14 days later. After evalsuation and discharge, no drug-related adverse events of grade 2 or above were observed during the entire CAR-T treatment process, including the most common cytokine storm and neurotoxicity in CAR-T treatment. After reinfusion, CAR-T cells can survive in vivo Rapid expansion and long-term maintenance. Now 3 years later, there are no cancer cells in the patient's body, and CAR-T cells are still patrolling and monitoring lymphoma, which can bring lasting benefits to the patient. In addition to Mr. Sun , and more than 20 patients have participated in this project, and all have achieved good results. Currently, the registration clinical trial of this non-viral CAR-T cell therapy by BRL Medicine is actively being carried out, showing that it is effective in specific lymphomas. It is very effective and we look forward to its early release to benefit patients. We also hope that BRL Medicine can develop more and better products for more indications to benefit more cancer patients."
BRL-201 therapy is safer, more effective and more accessible. BRL-201, indicated for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL), is based on the non-viral site-specific integrated CAR-T platform (Quikin CART®) independently developed by BRL Medicine. The CAR-T product had obtained Investigational New Drug Application(IND) approval from CDE,NMPA on December 14, 2022, and officially entered clinical stage I.
