Precision Bio Announces pCAR-19B (Pujilunsa Injection) for Pediatric and Adolescent Relapsed/Refractory B-ALL Included in CDE’s Priority Review

According to the CDE official website, Chongqing Precision Biotech Co., Ltd.'s pCAR-19B Cell Autologous Infusion Preparation (Pujilun Injection) was proposed for inclusion in the priority review category on June 27, intended for the treatment of 3-21-year-old patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia.

(Source: CDE)

According to publicly available data,pCAR-19B is a humanized CD19 CAR-T independently developed by Chongqing Precision Biotech Co., Ltd., which can significantly reduce the immunogenicity of CAR-T cells and prolong the persistence of CAR-T cells in the body.It is built based on the PrecisionCAR design strategy by Chongqing Precision Biotech Co., Ltd.

pCAR-19B was granted implied approval for registration clinical trials in children and adolescents with B-ALL in 2019.Phase 1 registered clinical trial data showed that all 9 enrolled patients achieved complete remission (CR), with an overall response rate of 100%., and minimal residual disease (MRD) was negative in all patients who achieved complete remission (CR) for the first time; no dose-limiting toxicity (DLT) or treatment-related deaths occurred, demonstrating good overall safety and tolerability.

Acute Lymphoblastic Leukemia (ALL) is a hematological malignancy originating from B-lineage or T-lineage lymphocytes. In adults, ALL mostly presents with an acute onset, with initial symptoms including fever, bleeding, progressive anemia, and bone or joint pain. Due to the high relapse rate, poor transplantation outcomes, and low long-term survival rates, the cure rate for adult ALL patients is significantly lower than that for pediatric ALL patients. Over the past decade, the emergence of new therapies such as molecular targeted drugs, immunotherapy agents, and cell-based treatments has improved the efficacy of ALL.

Currently, there is no CAR-T product for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) in children and adolescents approved for marketing in China. pCAR-19B is the first domestically produced CAR-T product for this indication to enter Phase 2 clinical trials.

In addition to targeting patients aged 3-21 with CD19-positive relapsed/refractory B-ALL, pCAR-19B has also been approved in China for clinical research on other indications, including: patients aged 22-70 with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia; and patients aged 75 or younger with relapsed/refractory CD19-positive diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma.

Reference: CDE official website