完全缓解率达100%的多款细胞疗法、可在1周内完成从制备到给药的CAR-T疗法... | 一周盘点

2023-12-17

细胞疗法临床1期免疫疗法临床结果快速通道

▎药明康德内容团队编辑本期看点1. 用于治疗复发性或难治性多发性骨髓瘤（MM）患者的CAR-T细胞疗法CART-ddBCMA的1期临床研究结果积极，所有受试者的总缓解率（ORR）达100%，估计的无进展生存期（PFS）为28个月。2. 在自体CAR-T细胞疗法MB-106针对复发或难治性惰性B细胞非霍奇金淋巴瘤（NHL）患者的1/2期临床试验中，滤泡性淋巴瘤（FL）和华氏巨球蛋白血症（WM）患者的ORR为100%，100%的FL患者（n=5）实现了完全缓解（CR）。3. 在自体CAR-T细胞疗法NXC-201用于治疗复发/难治性轻链（AL）淀粉样变性的1b/2a期临床试验中，患者的ORR为100%，CR率为70%。4. 在同种异体γ-δ T细胞疗法INB-100用于治疗接受异体造血干细胞移植的高危白血病患者的1期试验中，100%接受治疗的患者实现了持久的CR，包括高危和复发性急性髓系白血病（AML）患者以及既往多线治疗（包括CAR-T）失败的患者。5. 可在护理点制造的CAR-T细胞疗法GLPG5201和GLPG5101的1期临床试验结果积极，且从制备到回输到患者体内的中位时间仅需7天。药明康德内容团队整理CART-ddBCMA（anito-cel）：公布1期扩展试验数据 Arcellx公司公布了旗下细胞治疗产品CART-ddBCMA（现名为anitocabtagene autoleucel，anito-cel）的1期扩展研究的最新临床数据。Anito-cel cel是一款BCMA特异性CAR修饰T细胞疗法，旨在治疗复发性或难治性MM患者。此前，该疗法已被美国FDA授予快速通道资格、孤儿药资格和再生医学先进疗法认定。截至2023年10月15日的数据，中位随访时间为26.5个月，共有38名患者可进行疗效和安全性分析评估。根据国际骨髓瘤工作组（IMWG）标准，所有受试者的ORR达100%，并且带有预后不良因素的患者出现了深入而持久的缓解。中位PFS和OS尚未达到，Kaplan-Meier模型估计的PFS为28个月。▲根据Kaplan-Meier法估算的PFS率（图片来源：参考资料[6]）MB-106：公布1/2期临床试验数据Mustang Bio公司公布了其靶向CD20的自体CAR-T细胞疗法MB-106在针对复发或难治性惰性B细胞NHL患者的1/2期临床试验的数据。结果显示，MB-106在此类患者中的安全性良好，尽管未使用预防性药物，也没有发生1级以上的细胞因子释放综合征（CRS）和任何级别的免疫效应细胞相关神经毒性综合征（ICANS），且门诊给药是可行的。所有9名患者在接受MB-106治疗后均有缓解。FL和WM患者的ORR为100%。100%的FL患者（n=5）实现了CR。在WM患者中观察到1例非常好的部分缓解（PR）和2例PR。1名毛细胞白血病变异型患者此前一直严重依赖输血，治疗后病情持续稳定，不再需要输血。NXC-201（HBI0101）：公布1b/2a期临床试验的新数据Nexcella公司公布了其靶向BCMA的自体CAR-T细胞疗法NXC-201的1b/2a期临床试验的新数据。该研究旨在评估NXC-201用于治疗复发/难治性AL淀粉样变性的安全性和有效性。此前，NXC-201已被FDA授予孤儿药资格，用于治疗AL淀粉样变性和MM。截至2023年12月10日的数据，既往接受过大量治疗（中位治疗线数为6线）的患者的ORR为100%（10/10），CR率为70%（7/10）。患者的最佳缓解持续时间为23.7个月，并且缓解仍在持续。Nexcella公司计划在40名患者接受NXC-201治疗后，向FDA递交NXC-201的生物制品许可申请（BLA），用于治疗AL淀粉样变性。INB-100：公布1期临床试验的新数据 IN8bio公司公布了其同种异体γ-δ T细胞疗法INB-100在接受异体造血干细胞移植的高危白血病患者中的1期试验的新数据。结果显示，INB-100在这类患者中具有提供持久无复发治疗的潜力。截至2023年11月3日的数据，100%接受治疗的患者（n=10）实现了持久的CR，包括高危和复发性AML患者以及既往多线治疗（包括CAR-T）失败的患者。截至上次评估，所有受试者均存活，且没有复发，6名患者已经一年多没有复发。此外，在单次施用INB-100后365天，同种异体γ-δ T细胞依然保持着长期的体内扩增和持久性。该研究目前正在扩大患者招募，以进一步评估2期推荐剂量的疗效。GLPG5201、GLPG5101：公布1期临床试验数据Galapagos公司公布了其可在护理点制造的CAR-T细胞疗法GLPG5201和GLPG5101的1期临床试验结果。GLPG5201旨在治疗复发/难治性慢性淋巴细胞白血病（CLL）患者或小淋巴细胞淋巴瘤（SLL）患者，这些患者伴或不伴Richter转化（RT）。GLPG5101旨在治疗复发/难治性NHL患者。截至2023年9月6日的数据，接受GLPG5201治疗的14名疗效可评估的CLL患者的ORR为93%（13/14），CR率为57%（8/14）。9名RT患者的ORR为89%（8/9），CR率为67%（6/9）。接受较高剂量水平（DL2）的患者的ORR为100%（8/8），CR率为63%（6/8），6名RT患者的ORR为100%。在最初获得缓解后进展的3名患者中有2名已证实为CD19阴性疾病。截至2023年9月1日的数据，在研究的第一部分，接受GLPG5101治疗的14例可评估的NHL患者的ORR为86%（12/14），CR率为79%（11/14）。接受较高剂量水平（DL2）治疗的患者的ORR为86%（6/7），CR率也为86%。中位随访时间为8.6个月时，12名有缓解的患者中有8例（67%）保持持续缓解，持续时间长达15个月。在最初获得缓解后进展的4名患者中，有2例为CD19阳性复发，1例已证实为CD19阴性疾病。在研究的第二部分，7例可评估患者的ORR为86%（6/7），CR率为57%（4/7）。中位随访时间为3.2个月时，所有6名有缓解的患者均保持缓解。安全性方面，GLPG5201和GLPG5101均显示出令人鼓舞的安全性，大多数治疗伴发不良事件为1级或2级。此外，数据表明，这两种疗法从制备到回输到患者体内的中位时间仅需7天。P-BCMA-ALLO1 BCMA-ALLO1：公布1期临床试验数据Poseida Therapeutics公司公布了其与罗氏（Roche）共同开发的在研BCMA靶向同种异体CAR-T疗法P-BCMA-ALLO1 BCMA-ALLO1的1期临床试验的早期疗效和安全性积极结果，该疗法用于治疗复发/难治性MM患者。在该试验中，可评估患者（n=33）的随访时间至少4周，且皆接受了大量预治疗，中位既往治疗线数为7线。分析显示，在接受充分淋巴细胞耗竭的强化预治疗患者中，接受CAR-T疗法P-BCMA-ALLO1 BCMA-ALLO1治疗患者的ORR为82%（9/11），并具有深度临床缓解。在既往未接受过BCMA靶向双特异性T细胞衔接抗体治疗的患者中，其ORR为100%。该疗法展现良好的安全性和可靠性特征，所有意向治疗（ITT）患者均未观察到移植物抗宿主病（GvHD）或剂量限制性毒性，且观察到的CRS和神经毒性发生率较低（均≤2级）。Revumenib：公布1/2期临床试验数据Syndax Pharmaceuticals公司公布了其选择性小分子menin抑制剂revumenib联合氟达拉滨及阿糖胞苷用于携带NPM1突变或KMT2A重排的复发/难治性AML患者的积极结果。截至2023年11月1日的数据，所有9名患者均获得了形态学缓解，ORR为100%，其中78%的患者获得了复合完全缓解（CRc），其中44%的患者获得CR或是完全缓解伴部分血液学恢复（CRh）。试验中67%（6/9）的患者达到最小残留病（MRD）阴性状态。5名患者在获得缓解后接受了造血干细胞移植。两名患者开始接受revumenib的移植后维持治疗，并已持续缓解超过11个月。该组合疗法在复发和难治性患者人群中的耐受性良好，没有观察到新的安全信号。Acimtamig（AFM13）：公布1/2期临床试验数据Affimed公司公布了其潜在“first-in-class"的先天细胞衔接蛋白（ICE）acimtamig与同种异体自然杀伤（NK）细胞联用治疗复发/难治性霍奇金淋巴瘤（HL）的1/2期临床试验的最新数据。此次公布的数据显示，在所有剂量水平中，治疗方案的ORR为93%，CR率为67%；在接受推荐的2期剂量（RP2D）治疗的32例HL患者中，治疗方案的ORR为97%，CR率为78%。在所有剂量水平，中位无事件生存期（EFS）为8.8个月，中位总生存期尚未达到。对于接受RP2D治疗的HL患者，中位EFS为9.8个月，84%的患者在12个月时存活。接受RP2D治疗的HL患者的中位缓解持续时间为8.8个月。此外，治疗方案显示了良好的安全性和耐受性特征，无任何级别的CRS、ICANS或GvHD。WU-CART-007：公布1/2期临床试验数据Wugen公司公布了其同种异体现货型CAR-T细胞疗法WU-CART-007用于治疗复发/难治性T细胞急性淋巴细胞白血病（T-ALL）或淋巴细胞淋巴瘤（LBL）的全球1/2期临床试验数据。WU-CART-007靶向CD7，并能够防止CAR-T细胞自相残杀，降低发生GvHD的风险。此次公布的结果显示，WU-CART-007表现出可控的安全性，未观察到GvHD。在剂量水平≥2的18例疗效可评估的患者中，CRc为67%，接受RP2D治疗的患者的CRc为73%。没有患者产生针对供体的新型抗HLA抗体，在接受检测的18名患者中，未检测到针对CAR的抗药抗体。大家都在看作为药明康德旗下专注于细胞和基因疗法的CTDMO，药明生基致力于加速和变革基因和细胞治疗及其他高端治疗的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲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] Molecular Partners Presents Positive Initial Data from First Four Dosing Cohorts of Ongoing Phase 1/2a Trial of MP0533 for Patients with Relapsed/Refractory AML and AML/MDS at ASH Annual Meeting. 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Retrieved December 12, 2023, from https://investors.in8bio.com/news-releases/news-release-details/in8bio-announces-positive-clinical-update-demonstrating[21] Nurix Therapeutics Presents Positive Clinical Data from Its Novel Bruton’s Tyrosine Kinase (BTK) Degrader Programs, NX-5948 and NX-2127, at the 65th American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2023, from https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-positive-clinical-data-its-novel[22] NovalGen presents NVG-111 clinical data in hematological malignancies in an oral session and preclinical data for next-generation AR T cell engager NVG-222 at the 65th American Society of Hematology Annual Meeting. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793495/0/en/NovalGen-presents-NVG-111-clinical-data-in-hematological-malignancies-in-an-oral-session-and-preclinical-data-for-next-generation-AR-T-cell-engager-NVG-222-at-the-65th-American-Soc.html[23] Immix Biopharma Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793969/0/en/Immix-Biopharma-Announces-100-Overall-Response-Rate-n-10-23-7-months-Best-Response-Duration-ongoing-for-CAR-T-NXC-201-in-Relapsed-Refractory-AL-Amyloidosis-Patients-at-ASH-2023.html[24] NKARTA PRESENTS NKX101 CLINICAL DATA AT THE 2023 AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING & EXPOSITION. Retrieved December 12, 2023, from https://ir.nkartatx.com/news-releases/news-release-details/nkarta-presents-nkx101-clinical-data-2023-american-society[25] Adicet Bio Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study at the 65th American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2023, from https://www.businesswire.com/news/home/20231210950496/en[26] ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH. Retrieved December 12, 2023, from https://www.businesswire.com/news/home/20231210537316/en[27] Aptose Tuspetinib Clinical Data Featured in Oral Presentation at the 2023 ASH Annual Meeting. Retrieved December 12, 2023, from https://www.aptose.com/investors/news-events/press-releases/detail/283/aptose-tuspetinib-clinical-data-featured-in-oral[28] Aptose Tuspetinib Clinical Data Featured in Oral Presentation at the 2023 ASH Annual Meeting. Retrieved December 12, 2023, from https://www.aptose.com/investors/news-events/press-releases/detail/283/aptose-tuspetinib-clinical-data-featured-in-oral[29] Galapagos presents new encouraging data at ASH 2023 from ongoing CD19 CAR-T studies with GLPG5201 and GLPG5101. Retrieved December 12, 2023, from https://pipelinereview.com/index.php/2023121084951/DNA-RNA-and-Cells/Galapagos-presents-new-encouraging-data-at-ASH-2023-from-ongoing-CD19-CAR-T-studies-with-GLPG5201-and-GLPG5101.html[30] SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-MTM for the Treatment of Solid Tumors. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/12/2794702/0/en/SIRPant-Immunotherapeutics-Announces-FDA-Clearance-of-IND-Application-for-SIRPant-MTM-for-the-Treatment-of-Solid-Tumors.html[31] GigaGen Receives FDA Clearance of IND to Begin Phase 1 Trial of Oncology Drug Candidate, GIGA-564, in Solid Tumors. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/12/2794694/0/en/GigaGen-Receives-FDA-Clearance-of-IND-to-Begin-Phase-1-Trial-of-Oncology-Drug-Candidate-GIGA-564-in-Solid-Tumors.html[32] Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/12/2794706/0/en/Immuneering-Announces-FDA-Clearance-of-IND-Application-for-Phase-1-2a-Trial-of-IMM-6-415-to-Treat-Advanced-Solid-Tumors-with-RAF-or-RAS-Mutations.html[33] C4 Therapeutics Announces Positive Data from CFT7455 Phase 1 Trial in Relapsed/Refractory Multiple Myeloma. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/12/2795107/0/en/C4-Therapeutics-Announces-Positive-Data-from-CFT7455-Phase-1-Trial-in-Relapsed-Refractory-Multiple-Myeloma.html[34] Obsidian Therapeutics Announces Positive Interim Top-Line Clinical Data for OBX-115 Engineered TIL Cell Therapy in Advanced or Metastatic Melanoma Post-Anti-PD1 Therapy. Retrieved December 12, 2023, from https://www.businesswire.com/news/home/20231212231588/en[35] Black Diamond Therapeutics Announces Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent GBM. Retrieved December 14, 2023, from https://www.globenewswire.com/news-release/2023/12/13/2795402/0/en/Black-Diamond-Therapeutics-Announces-Topline-Results-from-Phase-1-Dose-Escalation-Trial-of-BDTX-1535-in-Patients-with-Recurrent-GBM.html[36] Black Diamond Therapeutics Announces Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent GBM. Retrieved December 14, 2023, from https://www.globenewswire.com/news-release/2023/12/13/2795402/0/en/Black-Diamond-Therapeutics-Announces-Topline-Results-from-Phase-1-Dose-Escalation-Trial-of-BDTX-1535-in-Patients-with-Recurrent-GBM.html[37] Shattuck Labs Announces Positive Initial Topline Data from Ongoing Phase 1 A/B Dose Expansion Clinical Trial of SL-172154 with Azacitidine in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) Patients. Retrieved December 14, 2023, from https://www.globenewswire.com/news-release/2023/12/13/2795366/0/en/Shattuck-Labs-Announces-Positive-Initial-Topline-Data-from-Ongoing-Phase-1-A-B-Dose-Expansion-Clinical-Trial-of-SL-172154-with-Azacitidine-in-Frontline-Higher-Risk-Myelodysplastic-.html[38] BioAtla Hosting Virtual R&D Day to Highlight BA3071 CAB-CTLA-4 Phase 1 Data in Multiple Solid Tumor Types. Retrieved December 14, 2023, from https://www.globenewswire.com/news-release/2023/12/13/2795508/0/en/BioAtla-Hosting-Virtual-R-D-Day-to-Highlight-BA3071-CAB-CTLA-4-Phase-1-Data-in-Multiple-Solid-Tumor-Types.html[39] Avidity Biosciences Reports Positive Data Demonstrating AOC 1044 Delivers Unprecedented Concentrations of PMO in Muscle Following a Single Dose in Healthy Volunteers from Phase 1/2 EXPLORE44™ Trial for Duchenne Muscular Dystrophy. Retrieved December 14, 2023, from https://www.prnewswire.com/news-releases/avidity-biosciences-reports-positive-data-demonstrating-aoc-1044-delivers-unprecedented-concentrations-of-pmo-in-muscle-following-a-single-dose-in-healthy-volunteers-from-phase-12-explore44-trial-for-duchenne-muscular-dystrophy-302013456.html[40] IECURE SECURES CLEARANCE FROM AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION FOR ITS CLINICAL TRIAL APPLICATION FOR THE OTC-HOPE PHASE 1/2 STUDY OF ECUR-506. Retrieved December 14, 2023, from https://iecure.com/news/iecure-secures-clearance-from-australian-therapeutic-goods-administration-for-its-clinical-trial-approval-for-the-otc-hope-phase-1-2-study-of-ecur-506/[41] SonALAsense Presents Preliminary Data From Clinical Study in Patients With Deadly Pediatric Brain Tumor. Retrieved December 14, 2023, from https://www.biospace.com/article/releases/sonalasense-presents-preliminary-data-from-clinical-study-in-patients-with-deadly-pediatric-brain-tumor/[42] SonALAsense Presents Preliminary Data From Clinical Study in Patients With Deadly Pediatric Brain Tumor. Retrieved December 14, 2023, from https://www.businesswire.com/news/home/20231213836300/en[43] Agomab Starts Phase 1 Clinical Study for AGMB-447 in Healthy Subjects and Patients with Idiopathic Pulmonary Fibrosis. Retrieved December 14, 2023, from https://www.businesswire.com/news/home/20231214772174/en/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