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ROCKVILLE, Md., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain from October 20th to 24th.
ROCKVILLE,Md。,2023年10月31日(GLOBE NEWSWIRE)-创新细胞治疗公司(ICT),一家临床阶段生物技术公司,开发全面的实体瘤嵌合抗原受体(CAR)T细胞疗法组合,今天宣布该公司于10月20日至24日在西班牙马德里召开的欧洲肿瘤内科学会(ESMO)2023大会上发表。
ICT presented updated data from its China-IRB study of GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in a poster presentation. Presentation details were as follows: A Phase 1 Dose Escalation Study of GCC19CART a Novel CoupledCAR® Therapy for Subjects with Metastatic Colorectal CancerAbstract: 4936Session Title: Colorectal cancer Date and Time: Sunday, October 22nd, 2023 at 12:00 to 13:00 CESTPresenter: Lucy Lu, MD, Chief Operations Officer of ICT This presentation highlights updated survival data from the 21 subjects who were enrolled in two dose escalation groups in IRB-approved studies in China.
ICT在海报展示中展示了其针对GCC19CART的中国IRB研究的最新数据,GCC19CART是该公司CouledCAR®技术的主要候选产品,旨在治疗复发/难治性转移性结直肠癌(R/R mCRC)患者。介绍细节如下:GCC19CART A新型CoupledCAR®治疗转移性结直肠癌受试者的1期剂量递增研究摘要:4936会议题目:结直肠癌日期和时间:2023年10月22日星期日12:00至13:00 CESTPresenter:医学博士Lucy Lu,ICT首席运营官本演示文稿重点介绍了在中国IRB批准的研究中参加两个剂量递增组的21名受试者的最新生存数据。
Of the 21 subjects who were enrolled on or before Dec 13, 2021, 13 subjects have been enrolled to dose level 1 (1x106 cells/kg) and 8 subjects have been enrolled to dose level 2 (2x106 cells/kg). The combined objective response rate (ORR) per RECIST 1.1 for both dose levels was 28.6% (6/21). For dose level 1, the ORR was 15.4% (2/13).
在2021年12月13日或之前登记的21名受试者中,13名受试者已被登记为剂量水平1(1×10 6个细胞/kg),8名受试者已被登记为剂量水平2(2×10 6个细胞/kg)。两种剂量水平的RECIST 1.1的综合客观反应率(ORR)为28.6%(6/21)。对于剂量水平1,ORR为15.4%(2/13)。
For dose level 2, the ORR was 50% (4/8) and the rest of the 4 subjects had a best overall response of SD for a disease control rate (DCR) of 100% out to three months. The most common adverse events were cytokine release syndrome (CRS) in 20/21 subjects (Grade 1 19/21 (90.4%) or Grade 3 1/21 (4.8%)) and diarrhea in 20/21 subjects (Grad.
对于剂量水平2,ORR为50%(4/8),并且4个受试者中的其余受试者在疾病控制率(DCR)为100%至3个月时具有SD的最佳总体响应。最常见的不良事件是20/21受试者(1级19/21(90.4%)或3级1/21(4.8%))的细胞因子释放综合征(CRS)和20/21受试者(Grad。