On April 20, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for the study of the anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) (Press release, JW Therapeutics, APR 20, 2022, View Source [SID1234612576]).
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B-cell acute lymphoblastic leukemia (B-ALL) is the most common malignancy in paediatric1. Resistance to chemotherapeutic agents resulting in disease relapse and progression, and survival following relapse is poor in patients with B-ALL. Salvage chemotherapy could be an option, but it is not sufficient to cure relapsed or refractory aggressive disease. Long term survival was limited due to poor response, low remission rate, and high relapse rate after salvage chemotherapy. At present, there is no standard effective treatment for r/r B-ALL. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) emerged as a promising strategy, nevertheless, the long-term survival rate still cannot achieve satisfaction2. Disease relapse after therapies remain a significant challenge, and novel treatment options are still urgently needed to prolong the long-term survival for patients with r/r B-ALL.
This study (JWCAR029-006) a phase I, open-label, single-arm, dose escalation study in China, which aims to evaluate the safety, efficacy, and pharmacokinetics profile of Carteyva in pediatric and young adult patients with r/r B-ALL, and also to determine the recommended phase II dose (RP2D).
About Relmacabtagene Autoleucel Injection (trade name: Carteyva)
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.