A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

开始日期2020-07-31

申办/合作机构

CRISPR Therapeutics AG

NCT04438083

/ Terminated临床1期

A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Advanced, Relapsed or Refractory Renal Cell Carcinoma With Clear Cell Differentiation

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory renal cell carcinoma.

开始日期2020-06-16

申办/合作机构

CRISPR Therapeutics AG

100 项与 CTX-130 相关的临床结果

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100 项与 CTX-130 相关的转化医学

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100 项与 CTX-130 相关的专利（医药）

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项与 CTX-130 相关的文献（医药）

2025-01-01·LANCET ONCOLOGY

Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study

Article

作者: Cullingford, Erika L ; Ganpule, Avanti ; Prica, Anca ; Dequeant, Mary-Lee ; Zain, Jasmine ; Iyer, Swaminathan P ; Keegan, Alissa ; Sica, R Alejandro ; Ho, P Joy ; Khodadoust, Michael S ; Kim, Youn H ; Huang, Elaine ; Li, Ziliang ; He, Qiuling Ally ; Hu, Boyu ; Ma, Anna ; Karnik, Sushant ; Patel, Janki N ; Horwitz, Steven M ; Foss, Francine M ; Nagar, Shashwat Deepali ; Weng, Wen-Kai ; Mendonez, Joy H ; Williams, Leah M ; He, Xinyi Shirley ; Huen, Auris O ; Beitinjaneh, Amer ; Sripakdeevong, Parin

BACKGROUND:

Effective treatment options are scarce for relapsed or refractory T-cell lymphoma. This study assesses the safety and activity of CTX130 (volamcabtagene durzigedleucel), a CD70-directed, allogeneic chimeric antigen receptor (CAR) immunotherapy manufactured from healthy donor T cells, in patients with relapsed or refractory T-cell lymphoma.

METHODS:

This single-arm, open-label, phase 1 study was done at ten medical centres across the USA, Australia, and Canada in patients (aged ≥18 years) with relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma, who had received at least one or at least two previous systemic therapy lines, respectively, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients underwent lymphodepletion with fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² (intravenously daily for 3 days), followed by intravenous CTX130 infusion at dose levels ranging from 3 × 10⁷ CAR+ T cells (dose level 1) to 9 × 10⁸ CAR+ T cells (dose level 4). The primary endpoint was the incidence of adverse events, defined as dose-limiting toxicities occurring within 28 days post-infusion. Secondary endpoints included objective response rate. Safety and activity analyses were performed on data from all patients who received CTX130. The trial is registered with ClinicalTrials.gov (NCT04502446) and EudraCT (2019-004526-25) and is closed to enrolment.

FINDINGS:

Between Aug 28, 2020, and May 30, 2023, 41 patients were enrolled and 39 (95%) received CTX130. The median patient follow-up was 7·4 months (IQR 3·1-12·2). 21 (54%) of 39 patients were female and 18 (46%) were male. 24 (62%) patients were White, eight (21%) were Black, three (8%) were Asian, three (8%) were from other racial or ethnic groups, and one (3%) was not reported. The median number of previous lines of anticancer therapy was 2·5 (IQR 1·3-4·0) for patients with peripheral T-cell lymphoma and 5·0 (IQR 5·0-7·0) for patients with cutaneous T-cell lymphoma. Cytokine release syndrome was the most common adverse event, occurring in 26 (67%) of 39 patients (23 were grade 1-2, two were grade 3, and one was a grade 4 dose-limiting toxicity at dose level 4). Grade 1-2 neurotoxic events were observed in four (10%) of 39 patients. The most common grade 3-4 adverse events were neutropenia (14 [36%]), anaemia (11 [28%]), and thrombocytopenia (six [15%]). Serious adverse events occurred in 25 (64%) patients, with CTX130-related serious adverse events in 14 (36%) patients, the most common related serious adverse event being cytokine release syndrome in 11 (28%) patients. 21 patients died, 16 from progressive disease and five from adverse events considered unrelated to CTX130 treatment. 18 of 39 patients (46·2% [95% CI 30·1-62·8) had an objective response. Of those treated at dose level 3 and higher, 16 of 31 patients (51·6% [33·1-69·8]) had objective responses, including six (19·4% [7·5-37·5]) with complete response and ten (32·3% [16·7-51·4]) with a partial response.

INTERPRETATION:

In patients with heavily pretreated T-cell lymphoma, CTX130 showed manageable safety and a promising objective response rate. This study shows that allogeneic, readily available CAR T cells can be safely given to patients with relapsed or refractory T-cell lymphoma. A next-generation CAR T-cell therapy containing additional potency gene edits (CTX131) is in clinical development.

FUNDING:

CRISPR Therapeutics.

2024-07-01·Cancer discovery

CD70-Targeted Allogeneic CAR T-Cell Therapy for Advanced Clear Cell Renal Cell Carcinoma

Article

作者: He, Qiuling Ally ; Klobuch, Sebastian ; Hurwitz, Michael E. ; Tannir, Nizar M. ; Pal, Sumanta K. ; Sacher, Adrian ; Budde, Lihua E. ; Yuen, Rachel R. ; Harrison, Simon J. ; Karnik, Sushant ; Patel, Sagar S. ; Meza, Luis ; Morrow, Phuong K. ; Ma, Anna ; Dar, Henia ; Dequeant, Mary-Lee ; Gurary, Ellen B. ; Keegan, Alissa ; Williams, Leah M. ; Tran, Ben ; Haanen, John B.A.G. ; Heath, Heidi ; Srour, Samer A. ; Agarwal, Neeraj ; Guo, Changan

Abstract:

Therapeutic approaches for clear cell renal cell carcinoma (ccRCC) remain limited; however, chimeric antigen receptor (CAR) T-cell therapies may offer novel treatment options. CTX130, an allogeneic CD70-targeting CAR T-cell product, was developed for the treatment of advanced or refractory ccRCC. We report that CTX130 showed favorable preclinical proliferation and cytotoxicity profiles and completely regressed RCC xenograft tumors. We also report results from 16 patients with relapsed/refractory ccRCC who received CTX130 in a phase I, multicenter, first-in-human clinical trial. No patients encountered dose-limiting toxicity, and disease control was achieved in 81.3% of patients. One patient remains in a durable complete response at 3 years. Finally, we report on a next-generation CAR T construct, CTX131, in which synergistic potency edits to CTX130 confer improved expansion and efficacy in preclinical studies. These data represent a proof of concept for the treatment of ccRCC and other CD70+ malignancies with CD70− targeted allogeneic CAR T cells.Significance: Although the role of CAR T cells is well established in hematologic malignancies, the clinical experience in solid tumors has been disappointing. This clinical trial demonstrates the first complete response in a patient with RCC, reinforcing the potential benefit of CAR T cells in the treatment of solid tumors.See corresponding author Sumanta K. Pal discuss this research article, published simultaneously at the AACR Annual Meeting 2024: https://vimeo.com/932606570/887520f9cb

2023-01-09·Cancer discovery

Going after CD70 with CAR T, NK Cells

Article

Abstract:

CD70 has emerged as a promising solid tumor target for chimeric antigen receptor (CAR)–bearing T or natural killer (NK) cells, with one allogeneic CAR T-cell therapy, CTX130, showing preliminary efficacy in renal cell carcinoma. Further, assessments of a cord blood–derived CAR-NK alternative have started; the trial will be the first to use cryopreserved NK cells.

项与 CTX-130 相关的新闻（医药）

2025-11-24

·国际肿瘤医讯

全球首例肺癌CR！CAR-T让免疫沙漠病灶消失超1年！三箭齐发重创肺癌/肾癌/肝癌等

2025年11月7日，第40届癌症免疫治疗学会（SITC）年会上公布了一项重磅成果——全球首例非小细胞肺癌患者接受CAR-T细胞疗法后实现完全缓解的临床报道，该报道还成功入选大会“150佳摘要”。这一突破为CAR-T疗法在实体瘤领域（尤其是肺癌这一高发癌种）的落地“打开了一条关键门缝”。尽管后续仍需通过扩大患者样本量、开展多中心研究及延长随访时间，进一步验证该疗法的长期有效性与安全性，但此次从“0到1”的跨越已属极具价值的积极信号，成功填补了CAR-T疗法在肺癌临床应用中的数据空白。而随着CAR-T疗法在实体瘤领域的研究不断深耕，我们有理由相信，将会有越来越多让临床束手无策的实体瘤，被精准免疫疗法攻克！ ▲截图源自“businesswire” 里程碑！双受体A2B694 CAR-T攻克“免疫沙漠”肺癌，首例CR稳定超12个月 A2B694凭双受体设计，给CAR-T装上“智能安全锁”，精准杀瘤不“误伤” A2B694是一款基于A2Bio公司专有Tmod™平台开发的自体逻辑门控研究性细胞疗法，其核心优势在于平台独特的双受体设计——由靶向肿瘤细胞的激活剂与保护正常细胞的阻断剂组成，能精准实现对肿瘤细胞的选择性杀伤，同时避免损伤正常细胞。具体来看，A2B694的激活剂靶向肿瘤相关抗原间皮素（MSLN），相当于精准识别肿瘤的“靶向武器”，一旦识别到肿瘤细胞便立刻启动攻击；而阻断剂则靶向HLA-A*02，如同保护正常细胞的“安全开关”，碰到表达该分子的正常细胞就马上“刹车”停手。符合该疗法治疗条件的患者，其肿瘤细胞恰好缺失HLA-A02表达，正常细胞却稳定表达该分子。这就意味着，只有满足“MSLN阳性+缺失HLA-A02”双重条件的肿瘤细胞会被精准清除，保留HLA-A*02的正常细胞则能安然无恙。这一特性大幅提升了疗法的精准性，也显著拓宽了CAR-T疗法在实体瘤治疗中的应用安全窗口。若后续研究持续推进并成功落地，这款名为A2B694的CAR-T产品，有望成为靶向间皮素表达实体瘤（涵盖非小细胞肺癌、间皮瘤、胰腺癌、卵巢癌、结直肠癌等）的新型精准细胞治疗利器。 ▲图源“A2 BIO官网”，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 A2B694 CAR-T实现首例KRAS双突变肺癌完全缓解，疗效持续稳定超12个月 EVEREST-2研究（NCT06051695）是一项I/II期临床研究，核心目的在于评估CAR-T产品A2B694的安全性与有效性，该研究不仅纳入了9例不同类型的实体瘤患者，包括3例卵巢癌患者、2例胰腺癌患者，以及非小细胞肺癌、结直肠癌、胃食管癌和间皮瘤各1例，更诞生了首例非小细胞肺癌（NSCLC）患者接受CAR-T疗法后获得完全缓解的突破性案例，极具临床参考价值。此案例是一位携带KRAS G12V+STK11“双突变”的进展性转移性非小细胞肺癌患者，属于免疫沙漠型肿瘤。该亚型本身就与化疗免疫疗法耐药及不良预后密切相关，患者此前接受卡铂+培美曲塞+帕博利珠单抗（K药）的一线标准治疗后，病情依旧进展，陷入治疗困境。同时，该患者还满足两项严苛的入组条件——肿瘤间皮素（MSLN）高表达与HLA-A02基因缺失（LOH），而在肺癌患者中，同时符合这两项标准的人群占比不足10%，这让该案例的成功更显珍贵。患者入组接受全剂量CAR-T细胞回输治疗后，后续疗效节点呈现出持续向好的态势。结果显示：在A2B694输注第90天，CT检查显示靶病灶全部消失（详见下图），达到RECIST1.1标准下的完全缓解（CR）；第180天，经中央影像复核，正式确认这一完全缓解状态；第190天的PET-CT扫描未见疾病复发迹象。治疗后第6个月和第8个月，ctDNA检测结果持续显示KRAS G12V突变呈阴性，意味着肿瘤残留风险极低。治疗期间仅出现一次特殊情况，在第243天患者出现孤立性脑转移，但颅外病灶仍维持完全缓解状态。针对这一情况，患者接受了地塞米松+根治性伽马刀放射外科手术联合，术后第284天复查PET-CT显示，病灶持续消失；直至治疗满12个月时，CT检查仍未发现新的病灶，疗效保持稳定。 ▲图源“A2 BIO官网”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除曾经，CAR-T这项先进的治疗技术一直掌握在医疗水平发达的国家，很多病友在苦苦等待中遗憾离开。值得中国病友们振奋的是，“天价”疗法不再遥不可及，中国已成功研发出多款针对多款血液肿瘤及实体瘤的CAR-T疗法，并在国内多家知名癌症中心启动临床，主要针对CD70、GPC3、CEA、Claudin18.2等多种靶点，以及结直肠癌、非小细胞肺癌、肾癌、宫颈癌、卵巢癌等多款癌种。做过基因检测的患者，可自行查看基因检测报告，一旦发现存在上述突变，可将近期病理报告、基因检测报告等资料汇总后，提交至全球肿瘤医生网医学部（4006667998），初步评估是否有机会参加相关临床试验。一旦审核通过，有机会获得”天价“疗法免费治疗的机会。看不懂检测报告或想要明确相关靶点的患者，也可联系全球肿瘤医生网医学部，详细解读报告或了解检测详情。同种异体CD70 CAR-T疗法CTX130暴击肾细胞癌，中位总生存超20个月，1例无病生存3年肾细胞癌（RCC）约占所有癌症的3%，其中透明细胞肾细胞癌（ccRCC）是最常见的亚型。局限性肾细胞癌通常可通过部分或根治性肾切除术实现治愈，但约30%的患者会发生转移，需接受全身治疗。目前透明细胞肾细胞癌的治疗手段仍较为有限，而嵌合抗原受体（CAR）T细胞疗法的出现，为这类患者提供了全新的治疗方向。 CTX130是一款在研的首创性靶向CD70的同种异体CAR-T细胞疗法，基于CRISPR-Cas9基因编辑技术改造而成，核心研发目标是治疗晚期或难治性ccRCC。其基因编辑改造包含三大关键目标：一是将抗CD70 CAR表达盒插入T细胞受体α恒定区（TRAC）基因座；二是破坏β2-微球蛋白（β2M），消除主要组织相容性复合体（MHC）I类分子的表面表达；三是抑制CD70表达，以此减少同源杀伤并提升治疗效果。首次人体I期COBALT-RCC临床试验（NCT04438083）进一步验证了其临床价值，截至2023年10月9日，共有16例复发/难治性不可切除或转移性透明细胞肾细胞癌（ccRCC）患者（中位年龄63岁，年龄范围53-77岁）入组，所有患者均先接受了为期3天的淋巴清除治疗（氟达拉滨+抗利尿激素），随后接受CTX130 CAR-T细胞治疗。结果显示：16例纳入完整疗效分析集的患者中，无一人出现剂量限制性毒性，疾病控制率（DCR）高达81.3%。其中12例（75%）达到疾病稳定（SD），1例（6%）实现完全缓解（CR）；患者中位无进展生存期（PFS）为2.9个月（95%CI，1.7–6.0），中位总生存期（OS）长达20.5个月（95%CI，14.3–未达到）。 ▲图源“Cancer Discov”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除尤为值得关注的是，其中一例完全缓解的患者在治疗后未接受任何其他抗癌治疗，且3年后仍保持无病状态。该患者是一位64岁男性，确诊ccRCC后接受阿替珠单抗联合卡博替尼治疗，病情仍复发并转移至肺部、胸膜，随后入组该临床试验。接受CTX130治疗后，患者先达到部分缓解（PR），治疗第3个月便实现完全缓解（CR），且这一状态持续稳定，至治疗第18个月复查时，完全缓解状态仍未改变。 ▲图源“BMJ”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除此次临床试验首次报道了肾细胞癌患者通过CAR-T疗法获得完全缓解的案例，不仅印证了CTX130的显著疗效，更进一步证实了CAR-T细胞疗法在实体瘤治疗领域的巨大潜力。 GPC3 CAR-T疗法C-CAR031首次人体研究震撼公布！肝癌疾病控制率飙至90.9% 磷脂酰肌醇蛋白聚糖-3（GPC3）是一种参与调控细胞迁移、增殖与存活的硫酸肝素蛋白聚糖，其独特的表达特性使其成为肝癌靶向治疗的理想靶点。该蛋白在72%的晚期肝细胞癌（HCC）组织中呈高表达，且与患者术后转移风险显著相关；而在正常肝脏、肝硬化肝脏以及发育不良结节、肝腺瘤等良性病变组织中，GPC3均无表达。这一特性让靶向GPC3的治疗既能精准识别并打击癌细胞，又能避免损伤健康肝组织。基于此，阿斯利康针对性研发了靶向GPC3的自体CAR-T疗法——C-CAR031。 2024年美国临床肿瘤学会（ASCO）年会上，C-CAR031的首次人体临床研究（IIT）数据惊艳亮相。该研究针对的是多线治疗失败的晚期肝癌患者（既往接受过1-6线治疗），结果充分展现了C-CAR031可控的安全性与显著的抗肿瘤活性。本次研究共入组24例BCLC分期晚期的肝细胞癌患者，基线病情复杂且治疗难度大：其中83.3%（20/24）的患者伴随肝外转移，既往治疗中位线数达3.5线（范围1-6线），更有95.8%（23例）的患者此前接受过免疫检查点抑制剂（ICI）联合酪氨酸激酶抑制剂（TKI）治疗。入组患者分别接受了4个不同剂量水平（DL）的C-CAR031输注治疗。临床结果十分亮眼：在22例可评估疗效的患者中，客观缓解率（ORR）达到50.0%，疾病控制率（DCR）更是高达90.9%，肝内及肝外病灶中位缩小率高达44.0%，缩小范围覆盖3.4%-94.4%。截至中位随访5.82个月，经Kaplan-Meier估计，患者的中位无进展生存期（PFS）为4.27个月（95%CI，2.86-8.90）。 ▲图源“ASCO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除其中，剂量水平4组的C023号患者治疗效果尤为引人注目。接受C-CAR031治疗后，该患者的肿瘤呈现持续退缩的积极态势，仅治疗1.5个月时，肺部转移病灶便出现深度应答，影像学检查清晰显示肿瘤显著缩小，充分彰显了C-CAR031令人振奋的临床潜力。 ▲图源“ASCO”，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 CAR-T细胞疗法在血液系统恶性肿瘤的治疗领域已取得突破性进展，众多患者从中受益。令人欣慰的是，近年来全球的研究人员从未停止探索的脚步，持续钻研各种新型策略，致力于降低肿瘤抗原异质性，打破免疫抑制的困境，并在胃癌、脑瘤、胰腺癌、肝癌、结直肠癌等实体瘤领域取得了突破性进展！全球肿瘤医学部小编也期望随着越来越多明星靶点的涌现、技术的不断革新，CAR-T疗法可以早日突破价格和癌症治疗的瓶颈，造福更多的癌症晚期患者，实现长期带瘤生存、提高生存质量、降低复发风险的美好愿景！想寻求CAR-T、TCR-T、TIL疗法等国内外抗癌新技术帮助的患者，可将病理检查报告、治疗经历、近期影像学检查等资料汇总后，提交至全球肿瘤医生网医学部（400-666-7998），进行初步评估，或申请国内外抗癌专家会诊。参考资料 [1]Pal SK,et al.CD70-Targeted Allogeneic CAR T-Cell Therapy for Advanced Clear Cell Renal Cell Carcinoma. Cancer Discov. 2024 Jul 1;14(7):1176-1189. https://pmc.ncbi.nlm.nih.gov/articles/PMC11215406/ [2]Pal S,et al.558 CTX130 allogeneic CRISPR-Cas9–engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: results from the phase 1 COBALT-RCC study[J]. 2022. https://jitc.bmj.com/content/10/Suppl_2/A584 [3]Zhang Q,et al.Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC)[J]. 2024. https://meetings.asco.org/abstracts presentations/234377 [4]https://www.businesswire.com/news/home/20251031980313/en/A2-Biotherapeutics-Presents-Initial-Safety-and-Efficacy-Data-from-Ongoing-Phase-12-EVEREST-2-Study-Including-First-Report-of-a-Complete-Response-to-CAR-T-Cell-Therapy-in-a-Patient-with-NSCLC 本文为全球肿瘤医生网原创，未经授权严禁转载扫描添加病友群抗癌资讯｜新技术｜新药研发｜权威专家入群免费领取抗癌资料患者关心

2025-10-29

·国际肿瘤医讯

欢喜哥离世敲警钟！原来沉默癌早有对策，早筛+创新疗法+术后防火墙，每个环节都能救命

据“联合早报”2025年10月28日消息，香港资深艺人、曾在《使徒行者》中饰演“欢喜哥”、被观众亲切称为“绿叶王”的许姓老戏骨，于当日凌晨2时30分，因肾癌扩散引发多器官功能衰竭不幸离世，享年76岁。据悉，他生前长期带病工作，即便病危入院前仍坚持拍戏——一周前还能正常约访记者，却在短时间内病情急转直下陷入昏迷，最终回天乏术，生命的骤然落幕令人猝不及防，也让他的离去更添惋惜。而他的病逝更是揭开了肾癌这一“沉默杀手”的残酷面纱：早期症状隐匿，一旦出现转移往往预后极差。我们不禁追问：为何肾癌多发现即晚期？如何早期捕捉信号、从源头预防癌症？现阶段又有哪些抗癌新技术能为患者争取一线生机？小编也希望通过本文，让更多人认识并重视癌症的早期筛查与前沿治疗，真正做到早发现、早干预、早治疗，带着“珍惜当下、不惧时间、向阳而生”的态度守护健康。正如他曾在视频中传递的信念：“世界上什么都不公平，唯独时间最公平，努力不是为了得到更多，而是为了人生有更多的选择”！ ▲图源“zaobao”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除肾癌为何大多发现就是晚期？这三个核心原因必须重视！肾癌起源于肾脏，其中肾细胞癌（RCC）是最常见类型，约占肾癌总数的 90%。临床中多数患者确诊时已属晚期，背后核心原因可归结为三点： 1、缺乏早期筛查机制：与肺癌、乳腺癌等有常规推荐筛查项目的癌症不同，肾癌目前尚无广泛普及的常规筛查方案，多数人不会主动做肾脏相关检查（如肾脏超声、CT）。即便参与体检，项目也多以基础检查为主，若未针对性排查肾脏，早期微小肿瘤很容易被遗漏。 2、早期症状隐匿：肾癌早期肿瘤体积小，对肾脏及周围组织影响微弱，几乎不会出现明显症状。一旦出现腹部包块、腰痛（肿瘤压迫周围组织）、肉眼血尿（肿瘤侵犯肾盏或肾盂）等典型表现，往往意味着肿瘤已增大、侵犯周围结构甚至发生转移，此时病情多已进入中晚期。 3、转移早且“沉默”：肾癌具有早期转移的特性，转移初期（常见于肺、骨）多仅引发轻微、非特异性症状，比如轻微咳嗽、乏力、偶发骨痛。这些症状极易被误认为普通感冒、疲劳等常见问题，导致诊断延误，最终发现时病情已发展至晚期。早期筛查：抓住“无症状期”的黄金窗口欢喜哥的病情发展如此迅速，很可能与肾癌“早期隐匿”的特性直接相关。这类癌症早期极少出现“血尿、腰痛、腹部肿块”的典型三联征，导致多数患者确诊时已处于中晚期。遗憾的是，我国肾癌筛查覆盖率不足15%，多数患者直到出现明显症状才就医，最终错失最佳治疗时机。因此，针对性筛查成为挽救生命的关键环节。 01 明确高危人群，精准筛查根据《居民常见恶性肿瘤筛查和预防推荐（2025版）》，明确推荐以下人群为高危人群，应重点进行筛查： ①遗传史：一级亲属有肾癌（如肾细胞癌的某些亚型）家族史；家族中有肾癌病史者，尤其是有遗传性疾病（如HLRCC综合征、VHL综合征、遗传性乳头状肾细胞癌、BHD综合征等）者。 ②年龄55岁以上，尤其是男性。 ③有慢性肾病（如慢性肾病或肾功能不全），或长期接受透析者，尤其是多囊肾病患者。 ④吸烟、肥胖[体重指数（BMI）>30]、长期血压高人群。 ⑤长期使用某些药物（如非那西丁、非甾体抗炎药、利尿剂等）。 ⑥有职业暴露史者，如长期接触石棉、镉、有机溶剂等化学物质的人群（如报业印刷工人、焦炭工人、石油化工产品工作者等）。 ⑦饮食不健康者，如长期摄入高脂肪、高蛋白食物，较少食用新鲜水果和蔬菜，以及长期饮用过多咖啡者。除了肾癌外，全球肿瘤医生网还曾介绍过“26类常见肿瘤的高危对象识别与筛查建议（2025版）”。阅读原文了解详情：为何年年体检却查不出癌？最新指南公布26种癌症筛查“金标准”，99%的人后悔知道太晚 02 筛查手段：从超声到无创检测 ①肾脏检查：作为首选初筛手段，无创且便捷，能发现直径1厘米以上的肿瘤； ②尿常规检查：肾癌可能合并血尿，尿常规检查有助于发现隐血阳性或红细胞数目超标的情况，从而提示可能患有肾癌。 ③CT/MRI：超声发现异常后进一步检查，可明确肿瘤大小、位置及浸润范围。 ④遗传咨询和基因检测：对于有遗传性家族史的高危人群，建议先接受遗传咨询和基因检测，若携带突变则需加强筛查。癌症预防：从生活方式降低肾癌的发生风险肾癌的病因虽未完全明确，但可控危险因素已得到充分证实。结合《2025中国肿瘤整合诊治指南（CACA）—肾癌》及流行病学研究，从源头预防可显著降低发病风险。 01 管理高血压：保护肾脏健康高血压及其相关药物使用可能增加肾癌风险。定期监测血压，通过低盐饮食、运动或药物控制血压稳定，不仅护心也护肾。 02 控体重：避免代谢异常相关风险肥胖与肾癌发病密切相关，尤其是腹型肥胖者风险更高。有研究发现，通过合理饮食与规律运动将BMI控制在18.5-23.9的健康范围，可降低20%-30%的肾癌风险。 03 戒烟：最明确的防控措施吸烟是目前唯一公认的肾癌环境危险因素，正在吸烟者患病相对危险度达1.6。研究显示，戒烟后肾癌风险会随时间逐渐下降，戒烟10年以上者风险可接近非吸烟者水平。 04 其他防护：避免接触有害物质长期接触重金属、化学溶剂等职业人群需做好防护；避免滥用止痛药和含马兜铃酸的草药，减少肾脏损伤风险。肾癌治疗新突破：五大前沿疗法齐发力，为患者带来新曙光欢喜哥因肾癌扩散离世的悲剧，折射出晚期肾癌治疗曾面临的困境。肾细胞癌占肾癌病例的 90% 以上，传统化疗放疗效果有限，转移性患者五年生存率仅约 12%。但随着医学不断进步，各类前沿抗癌手段陆续问世，部分癌症患者也因此迎来了治愈的希望。下面，全球肿瘤医生网小编将为大家简单盘点几类表现突出的前沿抗癌手段，供癌友们参考。 01 靶免联合治疗：延长生存期近一倍 2025年4月25日，中国肾癌治疗领域迎来首个且唯一获批的一线靶免联合治疗方案，为中高危患者带来新希望。该方案由阿昔替尼（英立达®）联合特瑞普利单抗构成，专门用于中高危不可切除或转移性肾细胞癌（RCC）患者的一线治疗。 RENOTORCH研究数据显示：接受该联合治疗的患者，中位无进展生存期较对照组提升近1倍，疾病进展或死亡风险降低35%，临床获益显著。目前，这一联合治疗方案已获多个国内外权威指南的高级别推荐。且阿昔替尼已纳入医保，大幅提升了可及性。 02 CTX130 CAR-T：首次实现18个月持久完全缓解在第37届癌症免疫治疗学会年会（SITC）上，一则CTX130 CAR-T细胞治疗透明细胞肾细胞癌（RCC）的案例引发关注——患者成功实现持久完全缓解（CR），疗效惊艳！该案例中的64岁男性患者，确诊透明细胞肾细胞癌后，虽接受过阿替珠单抗联合卡博替尼治疗，但病情仍复发且癌细胞转移至肺部和胸膜。随后，患者入组CTX130治疗肾细胞癌的1期临床试验（NCT04438083）。治疗结果超出预期：患者接受CTX130治疗后先达到部分缓解（PR），治疗第3个月更奇迹般实现完全缓解（CR）；至治疗第18个月复查时，完全缓解状态仍持续维持。这也是异基因CAR-T细胞治疗在肾癌领域首次达成如此持久的完全缓解，为晚期肾癌治疗带来新突破。 ▲图源“BMJ”，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 03 γ-δT细胞：肾癌肺转移患者实现2年持久完全缓解 γδ-T细胞是罕见T细胞亚群，虽仅占T淋巴细胞的0.5%~5%，但功能全面强大，堪称T细胞中的“特种部队”。其独特优势在于兼具抗肿瘤与抗感染双重作用，是天然免疫与获得性免疫的“桥梁”，在免疫响应中不可或缺。《Anticancer Research》曾报道一则经典案例：一位61岁男性患者确诊位右侧透明细胞型肾细胞癌（3级，pT1b期）伴肺转移，行根治性肾切除术后接受3个月干扰素α（IFN-α）治疗，CT显示肿瘤负荷无明显变化。治疗转折出现在IFN-α洗脱期1个月后：患者通过白细胞分离术获取外周血单核细胞（PBMC），静脉注射IL-2与唑来膦酸，随后输注活化的Vγ2Vδ2T细胞。疗效令人振奋：患者多发性肺转移灶在回输Vγ2Vδ2 T细胞3个疗程后显著缓解，6个疗程后完全消失；完成最后一个疗程后，患者持续2年保持完全缓解（CR）状态（详见下图），且未接受额外针对肾癌的治疗。 ▲图源“anticancer research”，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 04 DC疫苗：无靶向可用肾癌患者获持久完全缓解树突状细胞疫苗（DC疫苗）通过从患者体内提取DC细胞、负载特定肿瘤相关抗原（TAA）后回输，激发自身免疫系统对抗癌症。《抗癌研究》杂志曾报道一项“新抗原肽脉冲DC疫苗单药治疗晚期实体肿瘤”的临床研究，多例患者治疗反应良好且无严重不良事件，其中一例肾细胞癌肺转移患者疗效尤为显著。该患者2018年7月术后2个月出现多发肺转移，因肺静脉血栓无法使用靶向药，遂于2019年1月起接受新抗原肽脉冲DC疫苗治疗。结果显示：接种3剂后获部分缓解（PR）；接种6剂后接近完全缓解（CR），肿瘤基本消失；2020年8月复查CT，证实其维持持久完全缓解（CR）（详见下图）。 ▲图源“Anticancer research”，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 05 益生菌联合免疫治疗：肾癌缓解率提升近4倍全球知名期刊《Nature Medicine》报道了一项1期临床研究（NCT05122546）：评估益生菌CBM588联合纳武单抗+卡博替尼，治疗晚期转移性肾细胞癌（mRCC）的疗效。结果显示：益生菌联合治疗组（CBM588+卡博替尼+纳武单抗）的客观缓解率（ORR）达74%，而对照组（仅接受卡博替尼+纳武单抗治疗）ORR仅20%，显著提高近4倍。此外，联合治疗组6个月无进展生存（PFS）率达84%，显著高于对照组的60%，无进展生存优势明显（详见下图）。 ▲图源“Anticancer research”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除抓好术后管理：筑牢复发/转移“防火墙”，护好来之不易的康复成果对已接受治疗的癌症患者而言，复发转移是重要威胁。即便通过治疗清除了现存癌细胞，若术后未及时去除致癌高危因素，仍可能导致癌症卷土重来。据统计，约三分之一的肾癌患者会发展为转移性疾病，因此术后规范管理至关重要。 01 术后随访：动态监测病情变化指南推荐术后随访频率：前2年每3-6个月复查1次（含肾脏超声、血生化）；2-5年每6个月1次；5年后每年1次。高危患者需加做胸部CT或PET-CT，同时可通过三类检测早发现复发迹象： ①循环肿瘤细胞（CTC）检测：分析血液中脱落的恶性细胞，评估肿瘤存在状态、进展程度及治疗效果。 ②循环肿瘤DNA（ctDNA）检测：捕捉基因水平异常变化，先于影像学发现癌变，实现“早筛查、早发现、早诊断、早治疗”。 ③微小残留病灶（MRD）检测：发现治疗后残留的微量癌细胞，为评估复发风险、制定方案提供依据。 02 个性化疫苗：精准清除残留癌细胞 2025年《Nature》1期临床研究显示，肾癌个性化新抗原疫苗成效显著：9例晚期肾癌术后患者接受治疗后，中位随访3.3年均未复发，7例患者抗肿瘤T细胞数量飙升166倍。这类疫苗能为免疫系统发放“癌细胞通缉令”，精准识别并清除残留病灶，为高复发风险患者提供长期保护。 03 生活方式干预：巩固治疗效果术后保持健康体重、戒烟限酒、规律运动，同时控制血压血糖，可显著降低复发风险。 04 饮食调理：均衡营养降风险参考美国癌症研究所（AICR）与美国癌症协会（ACS）建议：合理搭配饮食（补充蛋白质，多吃新鲜果蔬、全谷物）；限制红肉及加工肉制品摄入（建议≤90g）；补充维生素、微量元素等，以提升免疫力、改善临床结局。 05 肠道菌群调节：筑牢免疫防线人体70%的免疫细胞集中在肠道，肠道菌群作为体内生态关键“守护者”，是癌症防治的“隐形防线”。科学调节不仅能夯实健康基础，还能提升抗癌及免疫治疗效果，缓解手术与放化疗副作用。主要调节方式包括：适当补充益生菌与益生元、粪便微生物组移植（FMT）、增加膳食纤维摄入等。小编寄语欢喜哥虽已不幸离世，但他在荧幕上塑造的经典形象从未真正远去。这份遗憾也再次为我们敲响健康警钟：日常生活中需密切关注身体变化、坚持定期体检，唯有如此才能实现疾病的早发现、早治疗。即便不幸确诊肾癌，也不必放弃希望——它虽治疗有难度，却并非 “无药可医、无法可治”。从戒烟控重的源头预防，到高危人群的定期筛查，再到先进疗法的规范治疗与术后的复发防控，每个环节都至关重要。现阶段，手术切除仍是肾癌的首选治疗方式，有手术机会的患者需尽早遵医嘱接受治疗；对于失去手术机会的晚期患者，也可结合自身病情选择适配的治疗方案。尤其近年来，随着新型靶向药物、免疫细胞疗法（如CAR-T细胞、γδ-T细胞）、癌症疫苗（如DC疫苗、mRNA疫苗）等不断涌现，为越来越多肾癌患者带来了长期生存的新可能。愿每一位癌友都能汲取这份力量，创造属于自己的抗癌奇迹。若您对当前治疗方案不满意，或希望了解 TIL 疗法、DC 细胞疗法、癌症疫苗、肠道菌群调节等新型抗癌技术，可将治疗经历、近期病理检查报告、出院小结等资料，提交至全球肿瘤医生网医学部（400-666-7998），获取初步病情评估或申请国内外抗癌专家会诊。参考资料 [1]Pal S,et al.558 CTX130 allogeneic CRISPR-Cas9–engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: results from the phase 1 COBALT-RCC study[J]. 2022. https://jitc.bmj.com/content/10/Suppl_2/A584 [2]Kobayashi H,et al. Complete remission of lung metastasis following adoptive immunotherapy using activated autologous γδ T-cells in a patient with renal cell carcinoma[J]. Anticancer research, 2010, 30(2): 575-579. https://ar.iiarjournals.org/content/30/2/575.long [3]Morisaki T,et al.Efficacy of intranodal neoantigen peptide-pulsed dendritic cell vaccine monotherapy in patients with advanced solid tumors: A retrospective analysis[J]. Anticancer research, 2021, 41(8): 4101-4115. https://ar.iiarjournals.org/content/41/8/4101 [4]Ebrahimi H,et al.Cabozantinib and nivolumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial[J]. Nature Medicine, 2024: 1-10. https://www.nature.com/articles/s41591-024-03086-4[5]https://anticancer.shac.org.cn/CN/Y2025/V38/I2/2 [6]https://www.zaobao.com.sg/entertainment/story20251028-7728618 本文为全球肿瘤医生网原创，未经授权严禁转载扫描添加病友群抗癌资讯｜新技术｜新药研发｜权威专家入群免费领取抗癌资料患者关心

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2025-08-19

·cingulate.com

Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights

Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026 KANSAS CITY, Kan., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the quarter ended June 30, 2025, and provided recent highlights. Recent Highlights: On July 31, 2025, Cingulate submitted its NDA to the FDA for CTx-1301, a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver a fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. The FDA guides that a decision is often made regarding acceptance of the NDA within 60 days. Submission of the NDA came after the following second quarter activities: Pre-NDA meeting with the FDA; Announcement of positive top-line results from the high dose (50mg) fed/fast study of CTx-1301, demonstrating that CTx-1301 can be taken with or without food; and Announcement of results of Phase 3 pediatric study of CTx-1301, demonstrating marked improvement of ADHD symptoms at week five, illustrating the potential benefits of the product and the value of the Precision Timed Release Platform. In addition, on July 21, 2025, Cingulate entered into a purchase agreement with Lincoln Park Capital, pursuant to which Lincoln Park agreed to purchase from the Company from time to time, over the 36-month term of the agreement and at the Company’s sole discretion, up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the purchase agreement). Jay Roberts, Executive Chairman of Cingulate’s Board of Directors, stated, “Submission of the NDA to the FDA for lead asset CTx-1301 marked a pivotal moment in Cingulate’s progression, reflecting years of dedication to developing a truly differentiated ADHD treatment through the Precision Timed Release platform. In addition, the recently executed agreement with Lincoln Park Capital allows management to be opportunistic in its capital needs as we prioritize pre-commercial activities in anticipation of the launch of lead asset CTx-1301 in mid-2026, pending FDA approval.” SECOND QUARTER RESULTS Cash and Working Capital: As of June 30, 2025, Cingulate had approximately $8.9 million in cash and cash equivalents, a $3.3 million decrease from December 31, 2024. The Company expects its cash will satisfy its capital needs into late 2025 under the current business plan. To advance the commercialization efforts for CTx-1301 into early 2026, the Company will need to raise approximately $1.5 million of additional capital. As of June 30, 2025, Cingulate had approximately $3.5 million in working capital, a decrease of $4.2 million as compared to $7.7 million as of December 31, 2024. R&D Expenses: Research and development expenses were $2.7 million for the three months ended June 30, 2025, an increase of $0.8 million or 43.6% from the three months ended June 30, 2024. This change was the result of an increase in both clinical and regulatory costs due to activities which occurred in the preparation of the NDA submission of CTx-1301, including data analysis costs and regulatory consulting costs, partially offset by a decrease in manufacturing costs. G&A Expenses: G&A expenses were $1.9 million for the three months ended June 30, 2025, an increase of $0.6 million or 47.1% from the three months ended June 30, 2024. This is primarily the result of an increase in legal and financial advisory fees. Net Loss: Net loss was $4.8 million for the three months ended June 30, 2025, compared to $3.2 million for the three months ended June 30, 2024. The increase in the net loss primarily relates to increased research and development costs as described above. About Attention Deficit/Hyperactivity Disorder (ADHD) ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined. About CTx-1301 Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. About Precision Timed Release™ (PTR™) Platform Technology Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025 and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. Investor & Media Relations: Thomas Dalton Vice President, Corporate Communications, Cingulate tdalton@cingulate.com(913) 942-2301

财报申请上市临床结果上市批准

100 项与 CTX-130 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
T细胞淋巴瘤	临床1期	美国	CRISPR Therapeutics AG	2020-07-31
T细胞淋巴瘤	临床1期	澳大利亚	CRISPR Therapeutics AG	2020-07-31
T细胞淋巴瘤	临床1期	加拿大	CRISPR Therapeutics AG	2020-07-31
弥漫性大B细胞淋巴瘤	临床1期	美国	CRISPR Therapeutics AG	2020-07-21
肾细胞癌	临床1期	美国	CRISPR Therapeutics AG	2020-06-16
肾细胞癌	临床1期	澳大利亚	CRISPR Therapeutics AG	2020-06-16
肾细胞癌	临床1期	加拿大	CRISPR Therapeutics AG	2020-06-16
肾细胞癌	临床1期	荷兰	CRISPR Therapeutics AG	2020-06-16
血液肿瘤	临床前	瑞士	CRISPR Therapeutics AG	-

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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


NCT04502446 (COBALT-LYM, Pubmed \| Lancet Oncol) 人工标引	临床1期	外周T细胞淋巴瘤 \| 皮肤T细胞淋巴瘤二线	39	CTX130	鏇糧範顧齋窪積膚選夢(築餘糧齋遞艱範顧齋襯) = 糧顧積壓壓鹹獵築蓋鬱獵鑰築獵窪鏇遞築鹹繭 (醖觸膚範鏇膚鑰鬱網廠 ) 更多	积极	2024-11-01
NCT04438083 (COBALT-RCC, AACR2024) 人工标引	临床1期	肾细胞癌	16	CTX130	鬱廠網襯壓襯衊夢醖膚(遞醖鹹構獵選築艱簾齋) = Doses ranging from 3 × 107 to 9 × 108 CAR T cells were administered, and no dose-limiting toxicities were encountered. 遞齋廠鏇襯蓋製淵蓋壓 (範艱獵選壓鹹齋願顧選 ) 更多	积极	2024-04-05
NCT04438083 (COBALT-RCC, SITC 12022 \| SITC 22022) 人工标引	临床1期	局部晚期透明细胞肾细胞癌	14	Fludarabine Phosphate 30mg/m2+Cyclophosphamide 500mg/m2+CTX-130	顧製顧鏇選鹹鏇蓋構艱(蓋簾艱鑰鏇觸簾遞鏇獵) = 積簾餘窪選廠鹹憲築夢齋積築觸築範鏇淵襯淵 (蓋繭鑰繭繭廠艱願衊遞 ) 更多	积极	2022-11-01
NCT04502446 (COBALT-LYM, EHA2022)	临床1期	肿瘤	17	CTX130	淵醖遞鹽蓋簾鑰衊餘艱(夢襯鬱壓襯鹽積壓構繭) = 繭鬱鑰鬱積鑰憲製鑰壓顧構選鹽遞夢糧顧窪淵 (鬱範膚選憲醖廠餘觸製 ) 更多	-	2022-05-12