CNCT19 (Inaticabtagene Autoleucel) is the China’s first independently developed CAR T-cell therapy in the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). On December 3, 2024, the long-term efficacy and safety of CNCT19 in adult r/r B-ALL was updated, and the result was published in Blood Advances.
Leukemia is one of the most common types of blood cancer. Adult acute lymphoblastic leukemia (ALL) has a high relapse rate, with approximately 60% of patients developing relapsed or refractory (r/r) B-ALL after initial treatment. The prognosis for adults with r/r B-ALL is extremely poor and often life-threatening, with survival typically ranging from just 2 to 6 months. Over the past 30 years, there has been little improvement in survival outcomes, highlighting a significant unmet clinical need. New, effective treatments are urgently required to extend survival and enhance the quality of life for these patients.
The study, led by Professor Wang Jianxiang from the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), served as the principal investigator. It evaluated the efficacy of CNCT19 injection in treating adults with relapsed or refractory B-ALL through a single-arm, open-label, multicenter pivotal clinical trial (NCT04684147).
A total of 48 patients with r/r B-ALL participated in the study. Among them, 72.9% had undergone two or more prior frontline therapies, and 16.4% had previously received hematopoietic stem cell transplantation.
Efficacy
With a median follow-up of 23.7 months, 41 out of 48 patients (85.4%) achieved minimal residual disease (MRD) negativity following CNCT19 infusion. The median duration of response was 20.7 months, and the median recurrence-free survival was 12.4 months. Additionally, the estimated 2-year overall survival rate was 55.2%, with 16 patients surviving beyond 24 months.
Safety
In the study, only 12.5% of patients experienced grade 3 or higher cytokine release syndrome (CRS), and 6.2% developed grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS). Importantly, there were no deaths related to CRS or ICANS. These findings confirm that CAR-T cells (CNCT19 injection) provide significant long-term clinical benefits in the treatment of adult r/r B-ALL.
About Juventas Biotech
Founded in June 2018, Juventas Biotech has grown into a leader in independent innovation within China’s cellular therapy industry, aiming to become a globally leading biopharmaceutical company driven by innovative cell and gene technologies. The company’s first core product, Yuanruida (CNCT19 Injection), was officially approved for market release by the National Medical Products Administration (NMPA) in November 2023. This product is the first CAR T-cell therapy for leukemia treatment in China and the country’s first fully independently developed CD19 CAR T-cell therapy.
Juventas Biotech collaborates closely with leading national research institutions and has established an international new drug development system centered around platforms such as CAR technology, iPSC technology, and gene editing technology. The company’s pipeline includes over 10 investigational products targeting hematologic malignancies, solid tumors, and autoimmune diseases.
About CNCT19
CNCT19 (Inaticabtagene Autoleucel Injection) is a CAR T-cell therapy product targeting CD19, developed with fully independent intellectual property rights. It features a unique CD19 scFv (HI19a) structure and an internationally advanced manufacturing process. The product has undergone three new drug clinical trial (IND) for the treatment of adult r/r B-ALL, relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma, and relapsed or refractory B-cell acute lymphoblastic leukemia in children and adolescents.
CNCT19 has been designated as a “Breakthrough Therapy” by the NMPA’s Center for Drug Evaluation and has been granted Orphan Drug Designation (ODD) by the U.S. FDA. In December 2022, the NMPA officially accepted the new drug application (NDA) for CNCT19 to treat adult r/r B-ALL and granted it priority review. In March 2023, the U.S. FDA also approved the IND application for CNCT19 to treat adult r/r B-ALL. In November 2023, CNCT19 Injection was officially approved for market launch by the NMPA.
