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New Clinical Trial for Relapsed Acute Lymphoblastic Leukemia

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JW Therapeutics announced 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).

B-cell acute lymphoblastic leukemia (B-ALL) is the most common malignancy in paediatric[1]. 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 satisfaction[2]. 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).

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