4
项与 Anti-EGFR/IL-13R alpha 2 CAR-T cell therapy(Tmunity Therapeutics/University of Pennsylvania) 相关的临床试验Phase Ib, Open-Label Study of CART-EGFR-IL13Rα2 Cells Administered Following Lymphodepleting Chemotherapy or Prior to Surgical Resection in Patients With EGFR-Amplified Recurrent Glioblastoma
This is an open-label, phase 1b study to evaluate different approaches for CART-EGFR-IL13Ra2 dosing and further characterize the safety, feasibility, preliminary efficacy, and pharmacokinetics of CART-EGFR-IL13Ra2 cells in patients with EGFR-amplified glioblastoma that has recurred following prior radiotherapy.
Phase 1 Open-label Study Evaluating the Safety of CART-EGFR-IL13R?2 Cells in Patients With Newly Diagnosed, EGFR-Amplified, MGMT-unmethylated Glioblastoma Following Completion of Initial Radiotherapy
This is an open-label phase 1 study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL3Ra2 (referred to as "CART-EGFR-IL13Ra2 cells"). Patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma who have undergone maximal safe surgical resection will be approached for initial study participation. A two-step screening/eligibility process will be utilized. Following informed consent, subjects who meet Step #1 Eligibility Criteria will remain on study and complete a course of radiotherapy (60 Gy) without temozolomide as per their routine cancer care. If there is no overt evidence of disease recurrence/progression following radiotherapy, additional screening tests/procedures will be performed. Subjects who then meet Step #2 Eligibility Criteria will undergo apheresis collection to initiate cell product manufacturing and surgical placement of a CSF-Ventricular Reservoir to allow for intracerebroventricular injection of the CART-EGFR-IL13Ra2 cells. All subjects will receive a single fixed dose of CART-EGFR-IL13Ra2 cells on Day 0 via intracerebroventricular delivery.
/ Active, not recruiting临床1期IIT Phase 1, Open-label Study Evaluating the Safety and Feasibility of CART-EGFR-IL13Ra2 Cells in Patients With EGFR-Amplified Recurrent Glioblastoma
This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy. This study will take place in two parts: an initial dose escalation phase followed by a dose exploration phase. In the dose expansion phase, the maximum tolerated dose (MTD) of CART-EGFR-IL13Ra2 cells will be determined using a standard 3+3 design. Once the MTD has been determined, the dose exploration phase will allow for further identification of a recommended dose for expansion (RDE) as well as the safety and feasibility of alternative dosing schedules.
100 项与 Anti-EGFR/IL-13R alpha 2 CAR-T cell therapy(Tmunity Therapeutics/University of Pennsylvania) 相关的临床结果
100 项与 Anti-EGFR/IL-13R alpha 2 CAR-T cell therapy(Tmunity Therapeutics/University of Pennsylvania) 相关的转化医学
100 项与 Anti-EGFR/IL-13R alpha 2 CAR-T cell therapy(Tmunity Therapeutics/University of Pennsylvania) 相关的专利（医药）
1
项与 Anti-EGFR/IL-13R alpha 2 CAR-T cell therapy(Tmunity Therapeutics/University of Pennsylvania) 相关的新闻（医药）胶质母细胞瘤（GBM）是成人最常见的原发性脑癌，患者中位总生存期（OS）仅12-15个月；对于一线放化疗后进展的复发性胶质母细胞瘤（rGBM），临床更是缺乏有效治疗手段。近年研究发现，CAR-T细胞疗法已在这一难治性疾病的治疗中展现出潜在应用价值。
2025年6月1日，宾夕法尼亚大学佩雷尔曼医学院的研究团队在全球权威期刊《Nature Medicine》上，公布了一项I期临床试验（NCT05168423）的振奋数据：针对EGFR扩增的rGBM患者，研究采用脑室内注射方式，使用靶向表皮生长因子受体（EGFR）表位806和白细胞介素13受体α2（IL-13Rα2）的二价CAR-T（CART-EGFR-IL13Rα2）细胞进行治疗，最终成功
减缓了近三分之二患者的肿瘤生长
。这一突破性进展不仅为长期陷入治疗困境的rGBM患者点亮了新生希望，更推动双靶点CAR-T疗法在脑癌领域迈出关键一步，有望改写胶质母细胞瘤的治疗格局，为更多难治性脑肿瘤患者开辟精准治疗新路径！
▲截图源自“Nature Medicine”
精准狙击复发胶质母细胞瘤！双靶点CAR-T让62%患者肿瘤消退
该研究共纳入18名复发性胶质母细胞瘤（rGBM）患者，所有患者均接受肿瘤切除手术后，通过鞘内注射将双靶点CAR-T细胞直接递送至脑脊液。
结果显示：在13名可测量疾病患者中，
62%（8例）患者治疗后出现肿瘤消退
：其中1例经神经肿瘤学改良疗效评估标准（mRANO）确认为部分缓解（PR），客观放射影像学缓解率为8%（90%Cl：0%-32%），另有1例患者病情持续稳定超16个月。患者中位无进展生存期（PFS）为1.9个月（90%Cl：1.1-3.4个月），截至数据截止时，中位总生存期尚未达到，中位随访时间为8.1个月。
▼游泳图（n=18）提示患者生存期
▲图源“Nature Medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除
▼中位无进展生存期
▲图源“Nature Medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除
值得一提的是，其中患者28的T1加权对比MRI图像尤为值得关注，其疗效已通过mRANO标准确认达到部分缓解（PR，详见下图）。
▲图源“Nature Medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除
小编寄语
十二年前，急性淋巴细胞白血病患儿Emily Whitehead在接受CAR-T细胞疗法治疗后，获得临床治愈，并存活至今的案例让CAR-T这款新型免疫细胞疗法一战成名！如今，我们很欣慰的看到，全球已有12款CAR-T产品获批上市，为无数饱受疾病折磨的血液肿瘤患者带来了新的希望与曙光！
更加欣慰的是，各国都纷纷加入CAR-T研发大军中，截至2023年，全球免疫细胞的临床研究项目已超2000项（ClinicalTrials.gov），其中仅CAR-T疗法一项就占据了近半数以上，这也彰显了CAR-T疗法在抗癌领域的广阔应用前景。而且近年来，研究人员不断更新CAR-T的新技术、发现新的靶点，尝试将其用于实体瘤治疗领域，并取得了不俗的疗效。全球肿瘤医学部小编希望CAR-T疗法可以早日突破价格和实体瘤治疗瓶颈，让越来越多的癌症患者获益，助其降低复发风险、实现长期带瘤生存的美好愿景！
参考资料
[1]Bagley S J,et al.Intracerebroventricular bivalent CAR T cells targeting EGFR and IL-13Rα2 in recurrent glioblastoma: a phase 1 trial[J]. Nature Medicine, 2025: 1-10.
https://www.nature.com/articles/s41591-025-03745-0
本文为全球肿瘤医生网原创，未经授权严禁转载
100 项与 Anti-EGFR/IL-13R alpha 2 CAR-T cell therapy(Tmunity Therapeutics/University of Pennsylvania) 相关的药物交易
