– First cleared CD19-CAR T IND application for generalized myasthenia gravis announced in the U.S. and fourth IND clearance for CABA-201 across a broad range of autoimmune diseases – – Clearance expands the clinical development of CABA-201 beyond rheumatology into neurology  – – Phase 1/2 clinical trial evaluating CABA-201 in generalized myasthenia gravis features parallel cohort design and a starting dose consistent with the previously announced Phase 1/2 trials of CABA-201 for lupus, myositis and systemic sclerosis – PHILADELPHIA, Nov.

-美国宣布首次清除CD19-CAR T IND应用于全身性重症肌无力，第四次清除CABA-201跨越广泛的自身免疫性疾病-清除将CABA-201的临床发展超越风湿病学扩展到神经病学-评估CABA-201在全身性重症肌无力中的1/2期临床试验具有平行队列设计和起始剂量与先前公布的CABA-201治疗狼疮，肌炎和系统性硬化症的1/2期试验一致-费城，11月。

06, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s fourth Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S.

062023（GLOBE NEWSWIRE）-Cabaletta Bio，Inc。（纳斯达克股票代码：CABA），一家临床阶段生物技术公司，专注于为自身免疫性疾病患者开发和推出第一种治疗性靶向细胞疗法，今天宣布该公司第四次研究新药（IND）申请CABA-201，一种含有4-1BB的全人CD19-CAR T细胞研究疗法，已被美国允许进行。

Food and Drug Administration (FDA) for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel gMG cohorts based on autoantibody status – one cohort of six patients with acetylcholine receptor (AChR) antibody-positive gMG and a second cohort of six patients with AChR antibody-negative gMG.

美国食品药品监督管理局（FDA）对重症肌无力（gMG）患者进行1/2期研究。该公司计划根据自身抗体状态在两个平行的gMG队列中启动CABA-201的1/2期临床试验-一组6名乙酰胆碱受体（AChR）抗体阳性gMG患者和第二组6名患者AChR抗体阴性gMG。

Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg. “While we remain on track to deliver initial clinical data from CABA-201 treated patients with lupus and/or myositis in the first half of 2024, we are continuing to expand our CABA-201 portfolio beyond rheumat.

与先前公布的针对狼疮，肌炎和系统性硬化症的CABA-201 IND应用许可一致，评估gMG中CABA-201的1/2期试验的起始剂量将为1×10 6个细胞/kg。“虽然我们仍在继续在2024年上半年提供CABA-201治疗的狼疮和/或肌炎患者的初步临床数据，但我们仍在继续将CABA-201产品组合扩展到rheumat以外。