Approval of The Clinical Trial Application of WuXi Giant Norricy Orenza Injection For r/r B-ALL

On April 20, WuXi Junuo announced that its CD19-targeting autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product, Benoda® (Rigiorenza Injection), is used for the treatment of children and A clinical trial application for young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) has been granted implicit approval by the National Medical Products Administration (NMPA) of China.

B-cell acute lymphoblastic leukemia (B-ALL) is the most common malignancy in children, and resistance to chemotherapeutic drugs often leads to relapse or disease progression, and patients after relapse often have poor survival rates. Although salvage chemotherapy is an optional treatment option, it has poor efficacy for aggressive relapsed and refractory patients, and the low remission rate and high relapse rate lead to very limited survival after salvage chemotherapy. There is currently no standard effective treatment for r/r B-ALL. Even after allogeneic hematopoietic stem cell transplantation (allo-HSCT), the long-term survival rate is still not optimistic, which brings great challenges to clinical treatment.

The approved study (JWCAR029-006) is a Phase I, open-label, single-arm, dose-escalating study in China to evaluate Benoda® in children and young adults with r/r B-ALL. The safety, tolerability, pharmacokinetics (PK) of the patients, and to determine the recommended dose for Phase II (RP2D).