上海、中国、12 年 2022 月 XNUMX 日 An independent and creative biotechnology company called JW Therapeutics (HKEX: 2126) focuses on developing, manufacturing, and selling cell immunotherapy products. At the 64th American Society of Hematology (ASH) Annual Meeting, the company presented the latest clinical data on Carteyva® (relmacabtagene autoleucel injection) in Chinese adults with relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory mantle cell lymphoma (r/r MCL).
あなたは読みたいかもしれません： 中国におけるCART細胞療法
中国における再発/難治性濾胞性リンパ腫の成人における Relmacabtagene Autoleucel の有効性と安全性 (抄録番号: 4640)
In this pivotal phase II RELIANCE study, patients who had histologically confirmed grade 1, 2, or 3a FL, with r/r disease were included. Eligible patients were randomized to receive relma-cel at the dose level of 100×106 または150×106 CAR T細胞, following lymphodepletion chemotherapy. At data cut-off (Dec 17, 2021), based on 28 patients with 11.7 months of median follow-up, relma-cel demonstrated remarkable clinical responses, achieving high rates of complete response rate (CRR) and overall response rate (ORR) (6 months ORR, CRR were 100% and 83.33% respectively), and a manageable safety profile (only 1 patient experienced Gr ≥3 neurotoxicity (NT), no Gr ≥3 cytokine release syndrome (CRS)). Updated safety and efficacy data with a longer follow-up will be presented.
あなたは読みたいかもしれません： 中国におけるCAR T細胞治療費
Preliminary Safety and Efficacy of Relmacabtagene Autoleucel (relma-cel) in Adult patients with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) in China (abstract number: 3326)
People with MCL who took part in this phase II single-arm open-label study in China got at least two types of treatment, such as anti-CD20 antibodies, anthracycline or bendamustine, and BTKis. After lymphodepleting chemotherapy, participants received relma-cel (100×106 CAR+ T cells). As of Nov 30, 2021, the preliminary data based on 11 patients provided promising clinical efficacy outcomes (best ORR 81.8%, best CRR 54.5%) in high risk patients with r/r MCL and a low incidence of grade ≥ 3 CRS (1 patient) and immune effector cell-associated neurotoxicity syndrome (ICANS, 1 patient). This study is ongoing, and further results will be presented.
レルマカブタジェンオートロイセル注（商品名：カルテイバ）について®)
Relmacabtagene autoleucel注射液（略称relma-cel、商品名：カルテイバ）®) is an autologous 抗CD19 CAR-T細胞免疫療法 JW Therapeutics が独自に開発した製品です。 CAR-T細胞 process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T製品 中国ではカテゴリー1の生物製剤として承認されています。現在のところ、それは唯一の 中国のCAR-T製品 これは、国家重要新薬開発プログラム、優先審査、および画期的な治療法の指定に同時に含まれています。
あなたは読みたいかもしれません： 中国における多発性骨髄腫に対するCAR T細胞療法
JW セラピューティクスについて
JW Therapeutics (HKEX: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing, and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors, and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading the healthy and standardized development of China’s cell immunotherapy industry.
