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An exploratory investigator-initiated trial via intrathecal orintracerebroventricular delivery of B7-H3-specifie allogeneicuniversal CAR-T cells in patients with recurrent high-gradegiomas
一项由研究者发起的通过鞘内或脑室内递送B7-H3特异性同种异体通用CAR-T细胞治疗复发性高级别胶质瘤患者的探索性试验
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Background: The MT027, developed by T-Maximum, is a B7-H3 (CD276)-directed genetically modified allogeneic T cell, targeting CD276-overexpressed tumor cells. Here, we reported a first-in-human, single-center, open-label investigator-initiated trial (IIT) via intrathecal or Intracerebroventricular delivery targeting recurrent high-grade glioma (ChiCTR2100047968). Methods: As of March 7, 2024, a total of 50 adult patients with recurrent high-grade glioma, B7H3+ expression, and KPS $40 were enrolled and administered at least one dose of MT027 (FAS), of whom, 32 received at least 3 doses (PPS1), 15 subjects with $3 doses and at least 1 efficacy visit (PPS2). 4 dose levels of 1.0, 1.5, 2.0, 2.53107 cells per injection were administered once every 4 weeks. Results: The overall results demonstrated the favorable tolerability, safety, |
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