▎WuXi AppTec Content Team Report

CBMG Biotech (AbelZeta) recently announced that itsFor CD20 or CD19 positive relapsed or refractory large B-cell lymphoma (r/r DLBCL)C-CAR039 CAR-T Cell Therapy Successfully Completes First Patient Infusion in Pivotal Phase 2 Confirmatory Clinical Trial. According to the press release from CBMG, this significant progress marks a solid step forward for CBMG in the field of cancer immunotherapy, further advancing the clinical application of innovative therapies.

Since its initial development, the C-CAR039 has undergone years of dedicated efforts by the Cellular Biomedicine Group (CBMG) team. They have successfully completed early exploratory investigator-initiated clinical studies (IIT studies) and Phase 1 IND clinical trials, verifying its safety and preliminary efficacy. The launch of this Phase 2 pivotal confirmatory clinical trial aims to further evaluate the efficacy and safety of C-CAR039 in a larger patient population, with the hope of bringing new treatment options to patients with relapsed or refractory large B-cell lymphoma.

C-CAR039 employs innovative CAR-T cell engineering technology, targeting CD20 or CD19 antigens.Capable of precisely identifying and eradicating tumor cells. Compared to traditional treatment methods, C-CAR039 demonstrates higher specificity and a lower risk of side effects, showcasing significant clinical advantages.

In 2023, the research findings of C-CAR039 were successfully selected for the 65th American Society of Hematology (ASH) Annual Meeting. The data showed that in the completed 48 cases of IIT research,Among 47 evaluable patients with relapsed or refractory NHL, the overall response rate was 91.5%, and the complete response rate was 85.1%.; When the median follow-up time reached 30.0 months, the median duration of response (DOR), median progression-free survival (PFS), and median overall survival (OS) were not reached;Of the 47 patients, 23 (48.9%) remained in complete remission (CR), with 10 of them lasting over 36 months.In addition to significant efficacy, C-CAR039 also demonstrated excellent safety, with only one patient (2.1%) experiencing Grade 3 cytokine release syndrome (CRS). In a cohort receiving a dose higher than the target dose, three patients developed Grade 1 or 2 immune effector cell-associated neurotoxicity syndrome (ICANS). All adverse reactions were relieved after treatment.

In 2022, C-CAR039 was granted Fast Track designation, Regenerative Medicine Advanced Therapy (RMAT) designation, and Orphan Drug designation by the U.S. FDA. In 2024, Cellular Biomedicine Group entered into an exclusive global collaboration with Johnson & Johnson to jointly develop and commercialize next-generation novel CAR-T cell therapy products C-CAR039 (targeting CD20/CD19) and C-CAR066 (targeting CD20) for the treatment of Non-Hodgkin's Lymphoma (NHL). The company received an upfront payment of $245 million and will be eligible for multiple milestone payments and sales royalties.

Chairman and CEO of CBMG Biotech, Liu Bizuo, stated:"We are very pleased to announce that the first subject has been infused in the pivotal confirmatory clinical trial of C-CAR039, for the development and commercialization of a novel CAR-T cell therapy for lymphoma."Based on the research results from IIT, the Phase 1 study of C-CAR039 continues to demonstrate the 'best-in-class' potential of this cell therapy in treating relapsed/refractory non-Hodgkin lymphoma (r/rNHL) among therapies of its kind, with the hope of addressing a significant unmet global medical need.Today marks an important milestone in the C-CAR039 clinical trial.We would like to thank all the research teams, clinicians, and patients who participated in and supported this project.The successful reinfusion of C-CAR039 not only validates our research and development strategy but also lays a solid foundation for future clinical studies.We will continue to make efforts, speed up the trial process, and strive to bring good news to more patients as soon as possible.”