A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647 to define a Phase 2 dose.

开始日期2021-02-24

申办/合作机构

Allogene Therapeutics, Inc.

100 项与 ALLO-316 相关的临床结果

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100 项与 ALLO-316 相关的转化医学

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100 项与 ALLO-316 相关的专利（医药）

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项与 ALLO-316 相关的文献（医药）

2023-09-01·Translational research : the journal of laboratory and clinical medicine

Rabies virus glycoprotein 29 (RVG29) promotes CAR-T immunotherapy for glioma

Article

作者: Chen, Zhengliang ; Zhang, Miaomiao ; Xu, Luxia ; Zhang, Fan ; Shi, Yan ; Jia, Shaochang ; Hu, Zhigang ; Ma, Ruiting ; Xu, Bin ; Lu, Xiao ; Liang, Junqing ; Long, Kaili ; Chen, Jiannan ; Du, Yu ; Zhang, Qi ; Wu, Heming ; Guo, Zhigang ; Li, Jun ; Xia, Mingyue ; Tang, Yong ; Ji, Feng

Chimeric antigen receptor T cell (CAR-T) therapy has limited efficacy for treating glioma because of the infiltrative nature of the blood-brain barrier (BBB) and T cell exhaustion. Conjugation with rabies virus glycoprotein (RVG) 29 enhances the brain-related efficacy of various agents. Here we assess whether RVG enhances the ability of CAR-T cells to cross the BBB and improves their immunotherapy. We generated 70R CAR-T cells (anti-CD70 CAR-T modified with RVG29) and validated their tumor-killing efficacy in vitro and in vivo. We validated their effects on tumor regression in a human glioma mouse orthotopic xenograft model as well as in patient-derived orthotopic xenograft (PDOX) models. The signaling pathways activated in 70R CAR-T cells were revealed by RNA sequencing. The 70R CAR-T cells we generated showed effective antitumor function against CD70⁺ glioma cells both in vitro and in vivo. 70R CAR-T cells were better able to cross the BBB into the brain than CD70 CAR-T cells under the same treatment conditions. Moreover, 70R CAR-T cells significantly promote the regression of glioma xenografts and improve the physical characteristics of mice without causing overt adverse effects. RVG modification enables CAR-T cells to cross the BBB, and stimulation with glioma cells induces 70R CAR-T cells to expand in a resting state. The modification of RVG29 has a positive impact on CAR-T therapy for brain tumors and may have potential in CAR-T therapy for glioma.

2023-07-01·Cancer immunology, immunotherapy : CII

Preclinical development and evaluation of nanobody-based CD70-specific CAR T cells for the treatment of acute myeloid leukemia.

Article

作者: Cheng, Jiali ; Jin, Jin ; Zhu, Xiaojian ; Mu, Wei ; Zhu, Li ; Dai, Zhenyu ; Zeng, Yuhao ; Wang, Jue ; Yang, Yongkun ; Cai, Haodong ; Hu, Guang ; Mao, Xia ; Huang, Liang ; Zhou, Jianfeng ; Ge, Tong

BACKGROUND:

Acute myeloid leukemia (AML) treatment remains challenging. CD70 was reported as a promising AML-specific antigen. Preclinically, CAR T-cell with single-chain-variable fragment (scFv) or truncated CD27 targeting CD70 has been reported to treat AML. However, various disadvantages including spontaneous exhaustion, proteinase-mediated loss of functional receptors, and high immunogenicity, limited its further application to clinical settings. Alternatively, the single-variable domain on heavy chain (VHH), also known as nanobodies, with comparable binding ability and specificity, provides an optional solution.

METHOD:

We generated CD70 knocked-out novel nanobody-based anti-CD70-CAR T-cells (nb70CAR-T) with two different VHHs for antigen detection. Next, we detected the CD70 expression on primary AML blasts by flow cytometry and associated the efficacy of nb70CAR-T with the target antigen density. Finally, epigenetic modulators were investigated to regulate the CD70 expression on AML cells to promote the functionality of nb70CAR-T.

RESULTS:

Our nb70CAR-T exhibited expected tumoricidal functionality against CD70-expressed cell lines and primary AML blasts. However, CD70 expression in primary AML blasts was not consistently high and nb70CAR-T potently respond to an estimated 40.4% of AML patients when the CD70 expression level was over a threshold of 1.6 (MFI ratio). Epigenetic modulators, Decitabine and Chidamide can up-regulate CD70 expression on AML cells, enhancing the treatment efficacy of nb70CAR-T.

CONCLUSION:

CD70 expression in AML blasts was not fully supportive of its role in AML targeted therapy as reported. The combinational use of Chidamide and Decitabine with nb70CAR-T could provide a new potential for the treatment of AML.

2022-07-18·Cancer research

Antitumor CAR T-cell Screening Platform: Many Are Called, but Few Are Chosen

Communications

作者: Adotévi, Olivier ; Galaine, Jeanne

Abstract:

Treatment with T cells expressing chimeric antigen receptors (CAR) is a promising anticancer therapy. However, this approach has several limitations and has not yet been effectively applied to treat solid tumors. The study by Panowski and colleagues represents the first comparative analysis of multiple single chain fragment variable (scFv)-based anti-CD70 CAR T-cell clones for the development of a clinical product to treat renal cell carcinoma (RCC). Despite the risk of T-cell fratricide due to CD70 expression on T cells, CD70 CAR T cells were produced successfully thanks to the protective CD70 masking phenomenon. Two distinct classes of CAR T cells were identified with different memory phenotypes, activation statuses, and cytotoxic activity. CD70 CAR T cells presented high cytotoxic activity against RCC both in vitro in RCC cell lines and in vivo in patient-derived xenograft mouse models. The off-target effects expected on the lymphoid compartment were confirmed by tissue cross-reactivity staining and in a cynomolgus monkey preclinical model with CD3-CD70 bispecific antibody treatment. The efficacy and the toxicity profile of the lead CD70 CAR T-cell candidate instigated the researchers to proceed with upscaled clinical production. This article emphasizes the influence of the scFv of the CARs on their efficacy:toxicity balance. Ultimately, they successfully managed to develop a highly effective CAR T-cell candidate to treat a solid tumor by an allogeneic approach, thereby overcoming two major hurdles to broaden application of CAR T-cell therapy.See related article by Panowski et al., p. 2610

项与 ALLO-316 相关的新闻（医药）

2024-11-10

·药明康德

总缓解率达96%的创新抗癌疗法；使多种癌症类型患者肿瘤缩小的合成致死疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 阿斯利康（AstraZeneca）双特异性T细胞接合器AZD0486治疗复发/难治性滤泡性淋巴瘤（R/R FL）患者的1期临床试验结果亮眼，接受2.4 mg及以上剂量患者的总缓解率（ORR）高达96%，完全缓解（CR）率达85%。 2. 潜在“first-in-class”的menin抑制剂revumenib联用venetoclax和去甲基化剂（HMA）ASTX727治疗携带特定基因变异的急性白血病患者，在一项1/2期研究中的ORR达88%。 3. 潜在“best-in-class”合成致死疗法TNG462的早期临床结果积极，多种癌症类型患者的肿瘤有缩小。药明康德内容团队整理 AZD0486：公布1期临床试验数据阿斯利康宣布将在今年的美国血液学会（ASH）年会上公布旗下多款血液学管线的临床结果，其中包括该公司的CD19 x CD3靶向双特异性T细胞接合器AZD0486用于复发/难治性滤泡性淋巴瘤患者的1期临床试验结果。结果显示，R/R FL患者对2.4 mg及以上剂量的AZD0486高度应答，患者的ORR高达96%，CR达85%，且患者的最小残留病灶（MRD）阴性比率很高。此外，1期试验中期结果也显示，接受过大量治疗的弥漫大B细胞淋巴瘤（DLBCL）患者也对AZD0486高度应答，患者的CR率高。最新数据还显示AZD0486具有良好的安全性，双倍递增给药方案可有效缓解患者发生细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）事件。 Revumenib：公布1/2期临床试验数据 Syndax Pharmaceuticals公司宣布将在ASH年会上公布其在研疗法revumenib联用venetoclax和去甲基化剂ASTX727（decitabine/cedazuridine）治疗携带KMT2A重排、NUP98重排或NPM1突变的复发/难治性急性髓系白血病（r/r AML）或混合谱系急性白血病（MPAL）儿童和成人患者的1/2期临床试验结果。Revumenib是一种针对menin-KMT2A相互作用的强效、选择性小分子抑制剂。截至2024年7月的数据，共有26名患者入组该试验，ORR为88%（23/26），CR或带部分血液学恢复的完全缓解（CRh）率为58%（15/26）。15名达到CR/CRh的患者中有14名的MRD状态可评估，其中93%（13/14）为MRD阴性。中位随访时间为6.6个月时，患者6个月时的无复发生存率为59%，总生存率为74%。CR/CRh患者的中位缓解持续时间尚未达到。该组合疗法总体上耐受性良好。 TNG462：公布1/2期临床试验数据 Tango Therapeutics公司宣布，基于在研疗法TNG462在1/2期临床试验剂量递增和早期剂量扩展队列中获得的积极数据，该公司已选择TNG462进入全面开发。新闻稿指出，TNG462是一种潜在“best-in-class”的甲硫腺苷（MTA）协同的蛋白精氨酸甲基转移酶5（PRMT5）抑制剂。PRMT5是甲硫腺苷磷酸化酶（MTAP）突变的合成致死靶点。MTAP基因缺失发生在大约10%的癌症中，包括胰腺癌、肺癌和膀胱癌，这些患者体内存在异常升高的MTA水平，从而抑制PRMT5的活性。PRMT5是一种参与基本细胞功能的酶，MTA的升高使得肿瘤细胞对额外PRMT5的抑制变得更为敏感。TNG462是一款基于合成致死理念设计的精准抗癌疗法，它可在抑制MTAP缺失细胞中PRMT5功能的同时，保留健康细胞中的PRMT5功能，从而选择性地杀死肿瘤细胞。截至2024年10月20日，共有59名患者入组，其中39名患者可评估，涵盖13种癌症类型。数据显示，TNG462在多种肿瘤类型中展现了抗癌活性且耐受性良好，包括非小细胞肺癌（NSCLC）和胰腺癌。多种肿瘤类型的肿瘤体积随着持续治疗而缩小，约60%最初被评估为疾病稳定（SD）的患者在之后出现部分缓解（PR）。尽管目前大多数癌症类型的患者数和随访时间不足以准确估算客观缓解率，但在已入组的7名胆管癌患者中，观察到其中3名（43%）患者获得确认的客观缓解。此外，TNG462在活性剂量下具有良好的安全性和耐受性，剂量限制性毒性（DLT）为血小板减少。该药物的其他不良事件（如恶心、呕吐、腹泻和疲劳）发生率低于20%，且主要为1级。 ▲TNG462治疗胆管癌患者的临床试验结果（图片来源：参考资料[4]） ISB 2001：公布1期临床试验的新数据 Ichnos Glenmark Innovation公司宣布将在ASH年会上进行口头报告，展示其三特异性抗体ISB 2001用于复发/难治性多发性骨髓瘤（r/r MM）的1期研究的数据。ISB 2001同时靶向MM细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。截至2024年7月的数据，12名可评估疗效患者的ORR为75%（9/12），其中包括1例MRD阴性的严格CR。安全性方面，ISB 2001具有良好的安全性和耐受性，未观察到DLT，仅有一例高于2级的特殊关注不良事件，且没有因治疗而停药的情况。 Vilastobart（XTX101）：公布1c期临床试验数据 Xilio Therapeutics公司公布了其正在进行的1c期临床试验的初步临床数据，该试验评估了vilastobart（XTX101）联用PD-L1抑制剂atezolizumab治疗晚期实体瘤患者的效果。Vilastobart是一种肿瘤激活、Fc增强、高亲和力结合的抗CTLA-4抗体。截至2024年10月7日，17名患者接受了vilastobart联用atezolizumab的治疗。观察到两名患有难以治疗的、免疫学上为“冷肿瘤”的患者达到了未确认的PR。在1名微卫星稳定型结直肠癌（MSS CRC）患者中观察到转移性肝脏病灶的完全消退。安全性数据显示，该联合治疗总体上耐受良好，vilastobart有潜力成为与PD-1/PD-L1抑制剂联合使用的差异化下一代抗CTLA-4抗体。 VK2735：公布早期临床试验的新数据 Viking Therapeutics在肥胖协会年会肥胖周（ObesityWeek）上公布了其在研减重疗法胰高血糖素样肽1（GLP-1）/葡萄糖依赖性胰岛素促泌肽（GIP）受体联合激动剂VK2735的最新临床试验数据。分析显示，接受每日VK2735口服片剂28天的受试者，其安慰剂调整后平均体重较基线减轻达6.8%。而接受每周VK2735皮下注射治疗13周的肥胖患者的平均体重则较基线减轻达14.7%。值得一提的是，在试验第一周时便观察到接受皮下剂型患者显著的体重减轻效果，近100%患者在停药4周后其体重减轻的大部分效果仍然维持。目前该公司正在规划VK2735注射剂型的3期研究，以及口服剂型的2期研究，详细信息将在接近试验启动时间时公布。 ▲接受口服VK2735治疗28天受试者的体重减轻效果（图片来源：参考资料[1]） ▲接受VK2735皮下注射13周受试者的体重减轻效果（图片来源：参考资料[1]） ▲接受VK2735皮下注射受试者在停药后体重减轻效果持续维持（图片来源：参考资料[1]） AZD5004：公布1期临床试验数据阿斯利康公司公布了在研口服GLP-1疗法AZD5004，在患有2型糖尿病的肥胖患者中进行的1期临床试验的最新结果。AZD5004是一款每日一次、低剂量的小分子GLP-1受体激动剂，该药物在临床前研究中证明具有理想的疗效和安全性。去年11月，阿斯利康与诚益生物（Eccogene）达成独家协议，以潜在18.25亿美元的总额获得小分子GLP-1受体激动剂ECC5004（即AZD5004），用于治疗包括肥胖症、2型糖尿病和其他合并症在内的适应症。此次公布的数据显示，接受剂量为50 mg的AZD5004治疗的患者中，4周后患者体重与基线相比降低5.8%，约为9.4斤。同时，患者的空腹血糖等指标也有所下降。 ▲AZD5004降低患者体重和血糖指标（图片来源：阿斯利康官网） CIN-109、CIN-110：公布1期临床试验数据 CinFina Pharma公司公布了其CIN-110的单剂量递增（SAD）研究的初步中期数据以及CIN-109的多剂量递增（MAD）研究的最终数据。CIN-110是一种强效、高选择性的肽YY（PYY3-36）类似物，具有延长的半衰期，旨在显著减少其他PYY分子观察到的恶心和呕吐，同时促进有效的长期体重减轻。CIN-109是一种新型长效生长分化因子15（GDF-15）类似物，有可能减少食欲、维持能量消耗和促进体重减轻，同时保持瘦体重。两项研究均显示这些候选疗法具有良好的耐受性，并能导致显著的体重减轻。CIN-110的1期研究共纳入24名平均BMI为34 kg/m²的肥胖受试者，在给药一周内，他们的食物摄入量减少了28%，体重最多下降了1.8%。总共报告了3例轻度恶心，通常在给药后12-48小时内出现，并在一天内缓解。在CIN-109的1期研究中，平均BMI为35 kg/m²的肥胖受试者的食物摄入量呈剂量依赖性的减少，最高达50%，患者在1-2个月内体重减轻了多达3.7%。此外，每两周给药一次CIN-109的耐受性更好，大部分减轻的体重来自于脂肪，且未观察到与治疗相关的严重副作用。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Viking Therapeutics Reports New Data from VK2735 Obesity Program at ObesityWeek® 2024. Retrieved November 4, 2024 from https://www.prnewswire.com/news-releases/viking-therapeutics-reports-new-data-from-vk2735-obesity-program-at-obesityweek-2024-302294915.html [2] AZN Meet the Management: Weight Management Virtual Event. Retrieved November 4, 2024, from https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/Weight-Management-Virtual-Event-IR-presentation.pdf [3] Tango Therapeutics Reports Positive TNG462 Clinical Data and Provides Update on PRMT5 Development Program. Retrieved November 6, 2024, from https://ir.tangotx.com/news-releases/news-release-details/tango-therapeutics-reports-positive-tng462-clinical-data-and [4] Tango Therapeutics Corporate Presentation. Retrieved November 6, 2024, from https://ir.tangotx.com/static-files/c49a558d-602e-4fed-9d53-dcbc004ffdf5 [5] AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024. Retrieved November 7, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-showcases-strength-of-haematology-portfolio-and-pipeline-at-ash-2024.html [6] Xilio Therapeutics Announces Initial Clinical Trial Data from Phase 1C Dose Escalation for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Advanced Solid Tumors. Retrieved November 7, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976781/0/en/Xilio-Therapeutics-Announces-Initial-Clinical-Trial-Data-from-Phase-1C-Dose-Escalation-for-Vilastobart-XTX101-a-Tumor-Activated-Anti-CTLA-4-in-Combination-with-Atezolizumab-in-Pati.html [7] CinFina Pharma Presents Positive Phase 1 Study Results in Poster Session for CIN-109 and in Late-Breaking Poster for CIN-110, Demonstrating the Potential of Next-Generation Mechanisms at ObesityWeek® 2024. Retrieved November 7, 2024 from https://cinrx.com/cinfina-pharma-phase-1-study-results-poster-session-cin-109-late-breaking-poster-cin-110-demonstrating-potential-next-generation-mechanisms-obesityweek-2024 [8] Ichnos Glenmark Innovation (IGI) Announces First Presentation of Data from Phase 1 Study of the Trispecific ISB 2001 in Relapsed/Refractory Multiple Myeloma (r/rMM) at Upcoming ASH Annual Meeting. Retrieved November 7, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2974962/0/en/Ichnos-Glenmark-Innovation-IGI-Announces-First-Presentation-of-Data-from-Phase-1-Study-of-the-Trispecific-ISB-2001-in-Relapsed-Refractory-Multiple-Myeloma-r-rMM-at-Upcoming-ASH-Ann.html [9] Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting. Retrieved November 7, 2024 from https://www.prnewswire.com/news-releases/syndax-announces-revumenib-abstracts-to-be-presented-at-the-66th-ash-annual-meeting-302296077.html [10] Oncoinvent Announces Publication of 18-Month Safety and Efficacy Data from the Phase 1/2a Study of Radspherin® in Colorectal Cancer. Retrieved November 5, 2024 from https://www.businesswire.com/news/home/20241101923447/en/Oncoinvent-Announces-Publication-of-18-Month-Safety-and-Efficacy-Data-from-the-Phase-12a-Study-of-Radspherin%C2%AE-in-Colorectal-Cancer/ [11] Arcellx to Present Clinical Data for Its Phase 1 and iMMagine-1 Studies in Patients with Relapsed or Refractory Multiple Myeloma at the 66th ASH Annual Meeting and Exposition and Announces Progress in iMMagine-3 Study. Retrieved November 5, 2024 from https://ir.arcellx.com/news/news-details/2024/Arcellx-to-Present-Clinical-Data-for-Its-Phase-1-and-iMMagine-1-Studies-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma-at-the-66th-ASH-Annual-Meeting-and-Exposition-and-Announces-Progress-in-iMMagine-3-Study/default.aspx [12] Beam Therapeutics to Present Data Across Hematology Franchise, Including First Clinical Data for BEAM-101 in Sickle Cell Disease and ESCAPE Non-human Primate Data, at American Society of Hematology (ASH) Annual Meeting. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2974971/0/en/Beam-Therapeutics-to-Present-Data-Across-Hematology-Franchise-Including-First-Clinical-Data-for-BEAM-101-in-Sickle-Cell-Disease-and-ESCAPE-Non-human-Primate-Data-at-American-Societ.html [13] TScan Therapeutics Announces Upcoming Oral Presentation of Data from the ALLOHA™ Phase 1 Heme Trial at the 66th American Society of Hematology Annual Meeting and Exposition. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2975010/0/en/TScan-Therapeutics-Announces-Upcoming-Oral-Presentation-of-Data-from-the-ALLOHA-Phase-1-Heme-Trial-at-the-66th-American-Society-of-Hematology-Annual-Meeting-and-Exposition.html [14] C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/06/2975566/0/en/C4-Therapeutics-Announces-First-Patient-Dosed-in-CFT8919-Clinical-Trial.html [15] Nouscom’s Off-the-Shelf Neoantigen Immunotherapy, NOUS-209, Continues to Elicit Potent and Durable Immune Responses in Lynch Syndrome Carriers Highlighting its Potential to ‘Intercept’ Cancer. Retrieved November 8, 2024 from https://www.morningstar.com/news/globe-newswire/1001011427/nouscoms-off-the-shelf-neoantigen-immunotherapy-nous-209-continues-to-elicit-potent-and-durable-immune-responses-in-lynch-syndrome-carriers-highlighting-its-potential-to-intercept-cancer [16] Korro Announces Regulatory Filing for Initiation of KRRO-110 First-In-Human Study and Formation of Clinical Advisory Board. Retrieved November 8, 2024 from https://ir.korrobio.com/news-releases/news-release-details/korro-announces-regulatory-filing-initiation-krro-110-first [17] Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW191 in Folate Receptor-⍺ Expressing Advanced Solid Tumors. Retrieved November 8, 2024 from https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-first-patient-dosed-phase-1-clinical-trial-0 [18] Ankyra Therapeutics Announces First Visceral Tumor Patient Dosed in Phase 1 ANCHOR Clinical Trial of ANK-101, an Anchored Interleukin-12 (IL-12). Retrieved November 8, 2024 from https://ankyratx.com/press-releases/ankyra-therapeutics-announces-first-visceral-tumor-patient-dosed-in-phase-1-anchor-clinical-trial-of-ank-101-an-anchored-interleukin-12-il-12/ [19] HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases. Retrieved November 8, 2024 from https://hifibio.com/hifibio-therapeutics-receives-fda-clearance-of-ind-application-for-hfb200604-a-best-in-class-btla-agonist-antibody-for-the-treatment-of-inflammatory-and-immunology-diseases/ [20] Xencor Doses First Subject in Phase 1/2 Study of XmAb®942 in Development for Patients with Inflammatory Bowel Disease. Retrieved November 8, 2024 from https://investors.xencor.com/news-releases/news-release-details/xencor-doses-first-subject-phase-12-study-xmabr942-development [21] Elicio Therapeutics Presents Updated Translational Data from ELI-002 Phase 1 AMPLIFY-7P Study at the Society for Immunotherapy of Cancer (“SITC”) 2024 Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2977121/0/en/Elicio-Therapeutics-Presents-Updated-Translational-Data-from-ELI-002-Phase-1-AMPLIFY-7P-Study-at-the-Society-for-Immunotherapy-of-Cancer-SITC-2024-Annual-Meeting.html [22] HotSpot Therapeutics Presents Additional Phase 1 Biomarker Data on Novel CBL-B Inhibitor HST-1011 at 2024 Society for Immunotherapy of Cancer Annual Meeting. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/hotspot-therapeutics-presents-additional-phase-1-biomarker-data-on-novel-cbl-b-inhibitor-hst-1011-at-2024-society-for-immunotherapy-of-cancer-annual-meeting-302298481.html [23] OncoResponse Announces Phase 1 Results of the Clinical Trial of OR502, anti-LILRB2 Antibody, in Subjects with Advanced Cancer. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/oncoresponse-announces-phase-1-results-of-the-clinical-trial-of-or502-anti-lilrb2-antibody-in-subjects-with-advanced-cancer-302298422.html [24] Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976851/0/en/Allogene-Therapeutics-Announces-Positive-Phase-1-Data-Demonstrating-the-Potential-of-ALLO-316-in-Heavily-Pretreated-Patients-with-Advanced-Renal-Cell-Carcinoma-at-SITC-and-IKCS.html [25] Bolt Biotherapeutics Presents Updated Preclinical Data for BDC-4182 and Key Learnings from Phase 1 Dose-Escalation Trial of BDC-1001 at SITC 39th Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976848/0/en/Bolt-Biotherapeutics-Presents-Updated-Preclinical-Data-for-BDC-4182-and-Key-Learnings-from-Phase-1-Dose-Escalation-Trial-of-BDC-1001-at-SITC-39th-Annual-Meeting.html [26] Aummune Announces Results from Phase 1 Trial of its Novel AM003 Immunotherapy for the Treatment of Solid Tumors. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976844/0/en/Aummune-Announces-Results-from-Phase-1-Trial-of-its-Novel-AM003-Immunotherapy-for-the-Treatment-of-Solid-Tumors.html [27] Cellenkos Announces Oral Presentation at ASH Annual Meeting 2024 Highlighting Phase 1b Clinical Data of CK0804 in Myelofibrosis. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/cellenkos-announces-oral-presentation-at-ash-annual-meeting-2024-highlighting-phase-1b-clinical-data-of-ck0804-in-myelofibrosis-302298808.html [28] Indaptus Therapeutics Presents Encouraging Interim Safety Data from Phase 1 Clinical Trial of Decoy20 at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976598/0/en/Indaptus-Therapeutics-Presents-Encouraging-Interim-Safety-Data-from-Phase-1-Clinical-Trial-of-Decoy20-at-the-Society-for-Immunotherapy-of-Cancer-SITC-2024-Annual-Meeting.html [29] Nimbus Therapeutics Presents Positive Updated Data from Phase 1/2 Clinical Trial of HPK1 Inhibitor for Advanced Solid Tumors at SITC 39th Annual Meeting. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107226079/en/Nimbus-Therapeutics-Presents-Positive-Updated-Data-from-Phase-12-Clinical-Trial-of-HPK1-Inhibitor-for-Advanced-Solid-Tumors-at-SITC-39th-Annual-Meeting [30] Indapta Therapeutics Presents Clinical and Preclinical Data of Allogenic Natural Killer Cell Therapy at Society for Immunotherapy of Cancer Meeting. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107081017/en/Indapta-Therapeutics-Presents-Clinical-and-Preclinical-Data-of-Allogenic-Natural-Killer-Cell-Therapy-at-Society-for-Immunotherapy-of-Cancer-Meeting [31] Radella Pharmaceuticals Announces Topline Data from the Phase 1a Study of MD-18, a First-In-Class Peptide Targeting PTP1B for Obesity. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107046414/en/Radella-Pharmaceuticals-Announces-Topline-Data-from-the-Phase-1a-Study-of-MD-18-a-First-In-Class-Peptide-Targeting-PTP1B-for-Obesity#:~:text=Radella%20Pharmaceuticals%20Announces%20Topline%20Data%20from%20the%20Phase,its%20platform%20targeting%20cardiometabolic%20disease%20and%20its%20adjacencies [32] Palisade Bio Announces First Subject Dosed in Phase 1 Clinical Study of PALI-2108 for the Treatment of Moderate-to-Severe Ulcerative Colitis (UC). Retrieved November 8, 2024 from https://palisadebio.com/palisade-bio-announces-first-subject-dosed-in-phase-1-clinical-study-of-pali-2108-for-the-treatment-of-moderate-to-severe-ulcerative-colitis-uc/ [33] SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M17D1 in Advanced Solid Tumors. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/systimmune-inc-announces-fda-clearance-of-ind-application-for-bl-m17d1-in-advanced-solid-tumors-302298993.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床2期临床1期

2024-11-09

·药明康德

多款缓解率超90%的细胞疗法临床结果亮眼；科济药业公布三款CAR-T疗法新进展…… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。Kite公司与Arcellx公司合作开发的创新嵌合抗原受体（CAR）-T细胞疗法anitocabtagene autoleucel（anito-cel）用于治疗复发或难治性多发性骨髓瘤（RRMM）患者的临床试验结果亮眼，患者的总缓解率（ORR）高达100%，完全缓解/严格完全缓解（CR/sCR）率近80%。科济药业宣布将展示其三款CAR-T细胞疗法泽沃基奥仑赛注射液（商品名：赛恺泽）、CT071和CT0590的临床试验数据。邦耀生物靶向CD19非病毒PD-1定点整合CAR-T细胞注射液针对自身免疫疾病的IND申请在中国获批。临床试验结果本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF ———✦研发进展✦——— ◇ 吉利德（Gilead）旗下Kite公司与Arcellx公司宣布将在今年的美国血液学会（ASH）年会上公布其联合开发的BCMA靶向CAR-T细胞疗法anito-cel用于治疗RRMM患者的临床试验最新结果。目前公布的摘要结果显示，接受anito-cel治疗患者的ORR高达100%，CR/sCR率近80%，且未在患者中观察到某些迟发性神经毒性的案例。相关临床3期研究iMMagine-3已于2024年下半年启动，并已完成了首例患者给药。 Anito-cel（原名ddBCMA）是采用Arcellx的创新紧凑型结合域D-Domain所开发的BCMA靶向CAR-T细胞疗法。该疗法已获得美国FDA的快速通道资格，孤儿药资格和再生医学先进疗法认定。Arcellx与Kite公司达成全球战略合作和许可协议，共同开发和商业化anito-cel用于治疗RRMM患者。目前，anito-cel在4线以上RRMM患者（iMMagine-1）和更早期治疗线患者（iMMagine-3）中进行临床研究。 ◇ TScan Therapeutics公司公布了在研T细胞受体（TCR）-T细胞疗法TSC-100和TSC-101在1期临床试验ALLOHA中的新数据。这两种疗法旨在治疗急性髓系白血病（AML）、骨髓增生异常综合征（MDS）或急性淋巴细胞白血病（ALL）患者在造血干细胞移植（HCT）后的残留疾病，并预防复发。TSC-100和TSC-101是TScan Therapeutics公司开发的TCR-T细胞疗法，分别靶向次要组织相容性抗原HA-1和HA-2。它们旨在与同种异体的HCT联用，消灭残余血液癌细胞，预防疾病复发。截至2024年7月8日的数据显示，所有接受TSC-100或TSC-101治疗的患者（n=16）没有出现复发，而按标准护理接受HCT的对照组（n=11）中有3例患者复发。TSC治疗组的中位复发时间无法评估，而对照组的中位复发时间为159天。所有5名随访达一年的TSC治疗患者在数据截止时仍无复发，且微小残留病（MRD）为阴性，这表明TSC治疗有效地清除了HCT后的残留癌细胞。在接受TSC-100或TSC-101输注后未发生剂量限制性毒性（DLT），治疗组和对照组的安全性相似，主要表现为预期的HCT后不良事件。该结果表明，TSC-100和TSC-101具有减少AML、ALL或MDS患者在减强度预处理的同种异体HCT后的复发率，并提高无复发生存率的潜力。 ◇ Beam Therapeutics公司宣布将在ASH年会上公布其在研自体CD34+碱基编辑造血干细胞疗法BEAM-101在1/2期临床试验BEACON中治疗镰状细胞病（SCD）患者的初步积极结果。摘要显示，该疗法成功提升SCD患者体内具功能性的胎儿血红蛋白（HbF）水平，为这款碱基编辑疗法提供临床上的概念验证。所有患者在第1个月内均迅速且显著地诱导了HbF的生成（>60%），并相应地降低了未输血血液中的镰状血红蛋白（HbS）水平（≤36%），且这一效果持续维持。此外，溶血标志物在所有4名患者中均已正常化或有所改善。Beam的试验目标是将HbF水平提高到至少60%，同时将HbS降至40%或更低。目前的患者队列规模较小，随访时间有限，但Beam公司已成功达到其预定试验目标。 ◇ Allogene Therapeutics公司公布了其用于治疗实体瘤的现货型CAR-T候选产品ALLO-316的1期临床试验TRAVERSE的积极结果。截至2024年10月14日的数据，既往接受过大量治疗的晚期或转移性肾细胞癌（RCC）患者接受了单次输注ALLO-316，CD70肿瘤比例评分（TPS）≥50%且接受剂量2（DL2）治疗患者的最佳ORR为50%，确认的缓解率为33%。在TPS≥50的患者中，76%（16/21）的肿瘤负荷减轻。接受1b期扩展方案的6例高TPS患者中有2例（33%）在≥4个月时表现出持续的缓解。 ▲TRAVERSE研究的结果（图片来源：参考资料[9]） ◇ Indapta Therapeutics公司公布了其同种异体自然杀伤细胞（NK）疗法IDP-023治疗晚期多发性骨髓瘤或非霍奇金淋巴瘤患者的1/2期临床试验结果。患者接受了1到3剂IDP-023，伴或不伴白细胞介素-2（IL-2）治疗。结果显示，在9名接受治疗的患者中，有5名患者观察到了客观缓解。在5名接受IDP-023和IL-2治疗的患者中，4名患者实现了客观缓解（1名非常好的部分缓解，2名部分缓解，1名轻微缓解）。安全性方面，IDP-023治疗总体上耐受性良好，没有DLT，最常见的不良事件是与预处理化疗相关的血细胞减少。 ◇ 科济药业宣布将在ASH年会上以壁报形式展示其三款CAR-T细胞疗法泽沃基奥仑赛注射液（商品名：赛恺泽）、CT071和CT0590的临床试验数据。 · 泽沃基奥仑赛注射液是一种全人源BCMA靶向自体CAR-T细胞疗法。在一项针对RRMM患者的2期临床试验中，102例接受过≥3线治疗（包括一种免疫调节药物和一种蛋白酶体抑制剂）的患者的客观缓解率为92.2%，CR/sCR率为71.6%。此外，患者的基线特征对该疗法的临床有效性影响不大，进一步说明即使是预后不良的RRMM患者也能够从中获益。 · CT071是一种全人源GPRC5D靶向的自体CAR-T细胞产品，生产时间仅需约30小时。在17例接受CT071治疗的RRMM患者（至少三线治疗失败或2类抗MM治疗药物耐药）中，ORR为94.1%（16/17），sCR率为52.9%（9/17）。有7例患者在第4周时就获得了CR或sCR。既往接受过BCMA或BCMA/CD19 CAR-T治疗的4例患者均获得了缓解（2例sCR，2例部分缓解）。安全性方面，11例（64.7%）患者出现了细胞因子释放综合症（CRS），均为1/2级。未观察到免疫效应细胞相关神经毒性综合症（ICANS），未发生DLT。 · CT0590是一种靶向BCMA和NKG2A的通用型CAR-T细胞疗法，通过TRAC/B2M/NKG2A三重基因敲除以减少移植物抗宿主病（GvHD）、宿主免疫排斥和自相残杀。在一项针对RRMM患者的1期临床试验中，中位随访时间为16.6个月时，有3例患者获得缓解，包括2例sCR和1例部分缓解。2例sCR患者中有1例RRMM患者的缓解持续时间（DOR）已达23个月（sCR仍在持续中），另1例原发性浆细胞白血病（pPCL）患者的DOR为20个月。安全性方面，未观察到≥3级CRS，也没有ICANS、GvHD、DLT和因不良事件导致的退出研究或死亡。 ◇ Cancer Immunology Research杂志上发表了一项评估CD27武装BCMA CAR-T细胞疗法CBG-002治疗RRMM患者的1期临床试验结果。中位随访时间为16.7个月时，11例接受CBG-002治疗患者的ORR为81.8%，CR/sCR率为45.5%，部分缓解率为18.2%，中位DOR为8.9个月，中位无进展生存期（PFS）为8.5个月，中位总生存期（mOS）尚未达到。安全性方面，没有患者出现≥3级的CRS或ICANS。其他3级或更高级别的不良事件包括中性粒细胞减少症（72.7%）、血小板减少症（45.5%）和贫血（36.4%）。 ◇ 邦耀生物宣布，其专有的非病毒定点整合CAR-T平台开发的名为“靶向CD19非病毒PD-1定点整合CAR-T细胞注射液”（BRL-203）的IND申请已取得中国国家药品监督管理局药品审评中心（CDE）的批准，针对的适应症为中度或重度难治性系统性红斑狼疮（SLE）。BRL-203不使用病毒载体，利用CRISPR/Cas9基因编辑技术对T淋巴细胞中PD-1位点精确编辑，定点插入表达靶向CD19的CAR分子的转基因。新闻稿指出，该候选产品此前在治疗复发或难治性B细胞非霍奇金淋巴瘤（r/r NHL）的临床试验中展现亮眼疗效，患者的客观缓解率高达100%，CR率达到85.7%，且患者长期获益显著高于现有同类病毒CAR-T产品。截至2024年2月10日的数据，mOS达到39个月，中位PFS达到了20个月。 ———✦融资、合作、M&A✦——— 图片来源：123RF ◇ 杭州瑞普晨创科技有限公司（简称“瑞普晨创”）宣布完成超亿元A轮融资。贝达药业同时发布新闻稿，宣布与瑞普晨创完成签署《战略合作协议》并进行投资，双方将合作开发干细胞治疗业务，在人多能干细胞向胰岛细胞诱导分化技术领域展开深入合作。瑞普晨创将化学重编程诱导多能干细胞（CiPSC）应用到临床级别制备体系，已在糖尿病治疗方向规划多条管线。目前，该公司自主研发的用于治疗1型糖尿病的多能干细胞产品RGB5088胰岛细胞注射液的IND已获得中国国家药品监督管理局（NMPA）受理。此前，《细胞》杂志上发表了CiPS制备胰岛细胞治疗1型糖尿病的临床研究结果。首例接受移植的患者恢复了内源自主性、生理性的血糖调控，移植75天后完全稳定地脱离胰岛素注射治疗，目前疗效已稳定持续1年以上，实现了临床功能性治愈。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Arcellx to Present Clinical Data for Its Phase 1 and iMMagine-1 Studies in Patients with Relapsed or Refractory Multiple Myeloma at the 66th ASH Annual Meeting and Exposition and Announces Progress in iMMagine-3 Study. Retrieved November 5, 2024 from https://ir.arcellx.com/news/news-details/2024/Arcellx-to-Present-Clinical-Data-for-Its-Phase-1-and-iMMagine-1-Studies-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma-at-the-66th-ASH-Annual-Meeting-and-Exposition-and-Announces-Progress-in-iMMagine-3-Study/default.aspx [2] Beam Therapeutics to Present Data Across Hematology Franchise, Including First Clinical Data for BEAM-101 in Sickle Cell Disease and ESCAPE Non-human Primate Data, at American Society of Hematology (ASH) Annual Meeting. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2974971/0/en/Beam-Therapeutics-to-Present-Data-Across-Hematology-Franchise-Including-First-Clinical-Data-for-BEAM-101-in-Sickle-Cell-Disease-and-ESCAPE-Non-human-Primate-Data-at-American-Societ.html [3] TScan Therapeutics Announces Upcoming Oral Presentation of Data from the ALLOHA™ Phase 1 Heme Trial at the 66th American Society of Hematology Annual Meeting and Exposition. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2975010/0/en/TScan-Therapeutics-Announces-Upcoming-Oral-Presentation-of-Data-from-the-ALLOHA-Phase-1-Heme-Trial-at-the-66th-American-Society-of-Hematology-Annual-Meeting-and-Exposition.html [4] 科济药业赛恺泽®、CT071和CT0590的数据将于2024年ASH年会上以壁报形式展示. Retrieved November 6, 2024 from https://mp.weixin.qq.com/s/Xf5qxHJR8nWR_pdYLxkzaA [5] Xu Y, Zhang X, Xin D, Zhang J, Wang L, Fan Y, Chen B, Lei W, Qiu X, Jiang H, Xiao X, Huang L, Yu J, Yang X, Yang W, Zhu J, Qian W. CD27-Armored BCMA CAR T Cell Therapy (CBG-002) for Relapsed and Refractory Multiple Myeloma: A Phase I Clinical Trial. Cancer Immunol Res. 2024 Oct 21. doi: 10.1158/2326-6066.CIR-24-0051. Epub ahead of print. PMID: 39432745. [6] 瑞普晨创完成超亿元A轮融资，资本市场布局糖尿病干细胞疗法. Retrieved November 1，2024, from https://mp.weixin.qq.com/s/nyUeHN2Vb5tQ-bldlZATVA [7]贝达药业携手瑞普晨创共拓细胞治疗新赛道. Retrieved November 1，2024, from https://mp.weixin.qq.com/s/TdWAbgQS77Gh9sfoa85gPA [8] JAMA Oncology 发表伊基奥仑赛注射液（福可苏®）用于治疗复发/难治性多发性骨髓瘤1b/2期临床研究数据. Retrieved November 1，2024, from https://www.prnasia.com/story/467921-1.shtml [9] Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976851/0/en/Allogene-Therapeutics-Announces-Positive-Phase-1-Data-Demonstrating-the-Potential-of-ALLO-316-in-Heavily-Pretreated-Patients-with-Advanced-Renal-Cell-Carcinoma-at-SITC-and-IKCS.html [10] Indapta Therapeutics Presents Clinical and Preclinical Data of Allogenic Natural Killer Cell Therapy at Society for Immunotherapy of Cancer Meeting. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107081017/en/Indapta-Therapeutics-Presents-Clinical-and-Preclinical-Data-of-Allogenic-Natural-Killer-Cell-Therapy-at-Society-for-Immunotherapy-of-Cancer-Meeting 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

细胞疗法孤儿药临床申请免疫疗法基因疗法

2024-11-08

·Firstwordpharma

Promising tumour response in Allogene trial tempered by fatal adverse events

Allogene Therapeutics delivered a mixed bag of results this week, revealing that its lead solid tumour CAR-T therapy ALLO-316 showed impressive anti-cancer activity in a Phase I trial – but also that three patient deaths were tied to the experimental treatment.The TRAVERSE study is evaluating ALLO-316, an off-the-shelf CAR-T candidate targeting the CD70 antigen, in patients with advanced or metastatic renal cell carcinoma (RCC). The company presented data from 26 patients evaluable for efficacy outcomes at The Society for Immunotherapy of Cancer's (SITC) annual meeting.ORR of 50%Among the six RCC patients with a CD70 tumour proportion score (TPS) of ≥50%, three had a response, resulting in an overall response rate (ORR) of 50%, with two (33%) achieving a confirmed response. They had received a dose of 80 million CAR-T cells following a standard lymphodepletion regimen. CEO David Chang called the efficacy results for ALLO-316 "unprecedented."Oppenheimer analysts echoed the sentiment, saying they were "encouraged by the degree of T-cell expansion…which appeared greater in magnitude than other CAR-T trials in solid tumours." Expansion occurred by day 10, eliminating CD70+ host T-cells while sparing CD70-cells. The analysts suggested the TRAVERSE findings validate Allogene's Dagger technology as a possible next-generation allogeneic platform that may eventually be able to reduce, or perhaps completely eliminate the need for extensive lymphoconditioning.Fatal events 'confounded' by factorsHowever, the trial also reported three Grade 5 treatment-related adverse events. According to Allogene, one case involved cardiogenic shock, which was one of two dose-limiting events in the study. The second fatal case was due to sepsis caused by a drug-resistant strain of Klebsiella pneumoniae, in a participant who had previously experienced a prior episode of muscle abscess and bacteremia from the same multi-drug-resistant strain. This participant was also being treated with anti-inflammatory medications to manage hyperinflammation.The third death involved "failure to thrive" in a participant 16 months after treatment with ALLO-316. Allogene said this person's cancer had remained stable at the 12-month check-up, but that they had had no additional scans to assess disease progression before they died.On a call with analysts, Chang acknowledged the complexity of these adverse events, stating "there is never a simple adverse event" when it comes to oncology patients with advanced disease, and that the fatal cases were "very confounded" by factors like the underlying disease and dosing.Read through to ALLO-329Allogene is also developing ALLO-329 – a CAR designed to target CD19 positive B cells and CD70 positive T cells – for autoimmune diseases. Like ALLO-316, it also incorporates Dagger technology, which equips AlloCAR T cells with a receptor that targets and depletes CD70-positive cells in the patient, while also masking the CD70 on the AlloCAR T cells themselves to stop them from attacking each other.When asked by an analyst whether Dagger could be contributing to the Grade 5 events or the overall safety profile, Chang said that "what [the technology] does is really enhance the pharmacodynamic effect of CAR T. So yes, to some extent – but at the end, this is really how you develop the ABCs of drug development." He indicated that finding the right balance between dose, safety, and efficacy remains a priority, and that this approach will guide their Phase I studies as they move forward with the ALLO-329 programme.

临床结果临床1期免疫疗法细胞疗法

100 项与 ALLO-316 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
肾细胞癌	临床1期	美国	Allogene Therapeutics, Inc.	2021-02-24
急性髓性白血病	临床前	美国	Allogene Therapeutics, Inc.	2020-11-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04696731 (TRAVERSE, AACR2023) 人工标引	临床1期	转移性透明细胞性肾细胞癌末线	17	ALLO-316	憲鹹製製願襯築製蓋築(艱積壓製淵壓鏇壓淵壓) = 蓋觸範襯襯齋遞衊繭簾齋艱糧獵觸廠窪鹹製憲 (鹽餘餘鹹積製鏇窪淵衊 ) 更多	积极	2023-04-14