A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

The main purpose of this study is to evaluate the Composite Complete Remission Rate (CRc) of WU-CART-007 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) patients and to evaluate the efficacy of WU-CART-007 to induce complete Minimum Residual Disease (MRD) negative response

开始日期2025-01-31

申办/合作机构

Wugen, Inc.

NCT05377827

/ Recruiting临床1期IIT

Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies

Effective treatment options for relapsed/refractory acute myeloid leukemia (AML) and T-cell non-Hodgkin lymphoma (T-NHL) represent a significant unmet medical need. CAR T therapy has offered durable remissions and potential cures in some forms of hematologic malignancy, including B-cell acute lymphoblastic leukemia. In AML, however, CAR T approaches have been limited by the lack of suitable antigens, as most myeloid markers are shared with normal hematopoietic stem cells and targeting of these antigens by CAR T therapy leads to undesirable hematologic toxicity. Similarly, T-NHL has not yet benefited from CAR T therapy due to a lack of suitable markers. One potential therapeutic target is CD7, which is expressed normally on mature T-cells and NK-cells but is also aberrantly expressed on
30% of acute myeloid leukemias. CAR T therapy for patients with CD7+ AML and T-NHL will potentially offer a new therapeutic option which has a chance of offering durable benefit.
WU-CART-007 is a CD7-directed, genetically modified, allogeneic, fratricide-resistant chimeric antigen receptor (CAR) T-cell product for the treatment of CD7+ hematologic malignancies. These cells have two key changes from conventional, autologous CAR T-cells. First, because CD7 is present on normal T-cells including conventional CAR T products, CD7 is deleted from WU CART-007. This allows for targeting of CD7 without the risk of fratricide (killing of WU-CART-007 cells by other WU-CART-007 cells). Second, the T cell receptor alpha constant (TRAC) is also deleted. This makes WU CART 007 cells incapable of recognizing antigens other than CD7 and allows for the use of an allogeneic product without causing Graft-versus-Host-Disease (GvHD).

开始日期2023-10-10

申办/合作机构

Washington University School of Medicine

[+1]

EUCTR2021-004324-14-FR

/ Not yet recruiting临床1/2期

A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T cells (WU-CART-007) in Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

开始日期2023-06-26

申办/合作机构

Wugen, Inc.

100 项与 WU-CART-007 相关的临床结果

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100 项与 WU-CART-007 相关的转化医学

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100 项与 WU-CART-007 相关的专利（医药）

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项与 WU-CART-007 相关的文献（医药）

Frontiers in Immunology

Case report: The case of T-cell acute lymphoblastic leukemia treated with chemotherapy followed by anti-CD7 CAR-T cells using retroviral vector

作者: Zhao, Lijun ; Li, Rongyou ; Liu, Liqiong ; Liu, Ning ; Ma, Qihong ; Jin, Mengdi ; Wang, Jianxun ; Zhu, Wenxiang ; Guo, Zhi ; Zhou, Huanhuan ; Sun, Rui ; Li, Huaxiu ; Shi, Yuanyuan ; Feng, Yaru

CD7-targeted chimeric antigen receptor-T (CAR-T) cell therapy has shown great promise in the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL). In this study, we reported a case of a 34-year-old male patient with T-ALL who finally developed multi-line drug resistance and refractoriness after multiple lines of high-intensity chemotherapy. After physician evaluation, this patient received allogeneic hematopoietic stem cell transplantation (allo-HSCT). Then, The patient remained in complete remission (CR) for four months before a relapse with 26.64% chimerism rate, so he was treated with allogeneic anti-CD7 CAR-T cells after chemotherapy reducing the tumor burden. The CAR-T product was a novel anti-CD7 CAR-T based on retroviral vectors (RV). After infusion, the patient achieved CR within 1 month after anti-CD7 CAR-T infusion and the remission has been ongoing for 9 months to date. Cytokine release syndrome (CRS) 1 was experienced while no immune effector cell-associated neurotoxicity syndrome (ICANS) was found. In addition, CAR copy number peaked at 350, 758 copies/μg on day 6. This case report of clinical treatment of T-ALL with anti-CD7 CAR-T cells prepared using a retroviral vector without gene editing and combined with chemotherapy, which demonstrated that the RV-based anti-CD7 CAR-T cells had good therapeutic effect and high safety in triple-refractory T-ALL patients.

Research square

Anti-CD7 allogeneic WU-CART-007 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma: a phase 1/2 trial

Article

作者: Irons, Haley ; Wu, Tony ; Muth, John ; Wood, Brent ; Del Rosario, Maria ; Calkoen, Frisco ; Rosario, Maria del ; Faramand, Rawan ; Boissel, Nicolas ; Baruchel, Andre ; Aldoss, Ibrahim ; Bajel, Ashish ; Ramsey, Brett ; Maude, Shannon ; Hamil, Alexander ; Bakkacha, Ouiam ; Jacobs, Kenneth ; Mattison, Ryan ; Baughman, Jan ; BOISSEL, Nicolas ; Zwaan, C ; Zwaan, C. ; Cooper, Matthew ; Christ, Stephanie ; Capoccia, Ben ; Rettig, Michael ; Wayne, Alan ; DiPersio, John ; Rijneveld, Anita ; Bhojwani, Deepa ; Gonzalez, Justo ; Ghobadi, Armin ; Dholaria, Bhagirathbhai ; McNulty, Eileen ; Davidson-Moncada, Jan

Abstract

Relapsed/refractory T-cell acute lymphoblastic leukemia (ALL)/lymphoma (LBL) represent a significant unmet medical need. WU-CART-007 is a CD7-targeting, allogeneic, fratricide-resistant chimeric antigen receptor T cell product generated from healthy donor T cells. WU-CART-007 was evaluated in a phase 1/2 study with a 3 + 3 dose-escalation design followed by cohort expansion in relapsed/refractory T-ALL/LBL. Patients received one infusion of WU-CART-007 after standard or enhanced lymphodepleting chemotherapy. The primary objectives, to characterize safety and assess the composite complete remission rate, were met. Of 26 patients enrolled, 13 received the recommended phase 2 dose (RP2D) of 900 million cells of WU-CART-007 with enhanced lymphodepletion. The most common treatment-related adverse event was cytokine release syndrome (88.5%; 19.2% grade 3–4). Biochemical abnormalities consistent with grade 2 hemophagocytic lymphohistiocytosis were seen in one patient (3.8%). Grade 1 immune effector cell-associated neurotoxicity syndrome events (7.7%) and one grade 2 acute graft-vs-host disease event occurred. Grade 5 events (11.5%) were due to fungal infection and multi-organ failure. The composite complete remission rate was 81.8% among 11/13 patients evaluable for response at the RP2D. WU-CART-007 at the RP2D demonstrated a high response rate in patients with relapsed/refractory T-ALL/LBL and has the potential to provide a new treatment option. ClinicalTrials.gov registration: NCT04984356.

项与 WU-CART-007 相关的新闻（医药）

2024-12-05

·GlobeNewswire-Health Care

Wugen to Present Clinical Data at the 2024 ASH Annual Meeting Ahead of Pivotal Trial Launch of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007

Data Support Start of First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy in Pediatric and Adult PatientsST. LOUIS and SAN DIEGO, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced upcoming scientific presentations, including updates from the company’s Phase 1/2 study of WU-CART-007. Researchers will present Phase 1/2 updates and studies for its investigational cell therapies this week at the American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 7-10 in San Diego. Results from Phase 1/2 showed continued anti-leukemic activity and clinically manageable safety in adults and adolescents. WU-CART-007 is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy under evaluation for treatment of patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Based on findings to date with WU-CART-007, including this week’s data, Wugen will initiate the first pivotal Phase 2 study for an off-the-shelf CD7-targeted CAR-T cell therapy. “Maturing evidence, including the Phase 1/2 study being presented, suggest WU-CART-007 has the potential to improve current standard of care for patients with these blood cancers. T-ALL/LBL are malignancies associated with high rates of relapse and mortality in patients, many of whom are young,” said Armin Ghobadi, M.D., professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) at the Washington University School of Medicine in St. Louis. “At this year’s ASH meeting, we will present clinical data from adult and adolescent patients that support our soon to open pivotal trial for patients with relapsed or refractory T-ALL/LBL,” said Wugen Chief Medical Officer, Cherry Thomas, M.D. “We are looking forward to working with experienced investigators to provide meaningful clinical benefit to patients with limited treatment options.” The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will involve two groups: a R/R cohort and subsequently an exploratory minimal residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia. Wugen Presentations at ASH 3450 WU-CART-007 (WT-7), an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results Presenter: Armin Ghobadi, M.D., Washington University School of Medicine, St. Louis Presentation type: PosterTime/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II 3461 WU-CART-007 (WT-7) Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) – Subgroup Analysis of WU-CART-007 1001 Presenter: Shannon L. Maude, M.D., Division of Oncology, Center for Childhood Cancer Research and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia Presentation type: PosterTime/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II Wugen researchers will also present the following abstracts for the company’s investigational memory natural killer cell therapy, WU-NK-101: 916 W-NK1 Choreographs Innate and Adaptive Immune Responses to Provide a Robust and Durable Anti-AML Response Presenter: Tom Leedom, Wugen, Inc., St. Louis Presentation type: Oral Time/location: Monday, Dec. 9, 3:30 p.m. PT; Marriott Grand Ballroom 8-9, Marriott Marquis San Diego MarinaSession: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Enhancing NK Cell Therapeutics Hematology Disease Topics & Pathways: Research, Translational Research 2:45-4:15 p.m. PT 4257 WUN101-01: First in Human (FIH) Phase 1 Study of WU-NK-101 (W-NK1) in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) Presenter: Amanda F. Cashen, M.D., Washington University School of Medicine, St. Louis Presentation type: PosterTime/location: Monday, Dec. 9, 6:00-8:00 p.m. PT; Halls G, HSession: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster IIIHematology Disease Topics & Pathways: Research, Clinical trials, Translational Research, Clinical Research Investigator-initiated research 2066 Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma Presenter: Michael H. Kramer, M.D., Ph.D., Washington University School of Medicine, Saint Louis Presentation type: PosterTime/location: Sat., Dec. 7, 5:30-7:30 p.m. PT; Halls G, HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I; About WU-CART-007 WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794. WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need. About Wugen Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com and follow Wugen’s LinkedIn page. Investor Contact:Mark LewisWugenMlewis@wugen.com314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com215-595-5211

细胞疗法免疫疗法快速通道临床2期ASH会议

2024-11-19

·晨泰医药

【2024 ASH】Wugen 将在2024 ASH汇报通用现货型CD7 CAR-T和NK细胞产品最新数据，5篇研究入选口头报告

新闻速览第66届美国血液学年会（ASH）将于2024年12月7日~10日在美国圣地亚哥召开。ASH作为全球血液学领域规模最大、涵盖最全面的国际学术盛会之一，每年吸引着成千上万名来自世界各地的专家学者，分享最前沿的血液学进展和突破性临床数据。根据ASH最新公布的摘要，Wugen公司有5项研究入选Oral Presentation，将以口头汇报形式报告通用现货型CD7 CAR-T（WU-CART-007)和NK细胞（WU-NK-101）疗法的最新数据。 CD7 CAR-T报告详情如下： 2066 Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I 3450 WU-CART-007 (WT-7), an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II 3461 WU-CART-007 (WT-7) Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) Subgroup Analysis of WU-CART-007 1001 Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II WU-CART-007已获FDA授予的孤儿药、快速通道和罕见儿科疾病认定、再生医学先进疗法认定；EMA优先审评药物认定。此次会议上，Wugen将报告通用现货型CD7 CAR-T疗法的最新临床数据,主要亮点包括： CD7 CAR-T治疗（R/R）T-ALL/LBL II期阶段试验结果：截至2024年7月24日，共13名患者接受了RP2D剂量治疗表现出可控的安全性以及抗白血病活性。可评估患者中，ORR和CRc分别为91%（10/11）和73%（8/11；6 CR，2 CRi）。中位DOR尚未达到（95% CI: 0.5，NE；范围0.5-9.1个月）；4名患者目前仍持续CR，时间分别为9.1、8.2、6.7和6.7个月。 MRD阴性CR/CRi患者（n=7）的中位DOR为6.6个月（95% CI：1.8，NE），而MRD阳性CR/CRi患者（n=3）为3.7个月（95% CI: 0.5，NE）。MRD阴性患者总生存期（OS）为11.5个月（95% CI：2.7，NE），MRD阳性患者为6.1个月（95% CI：1.4，NE）。 12-18青少年患者亚组分析中，可评估的患者（4/4）CR/CRi率为75%，1例患者达到PR（CD7阴性残留EMD），ORR为100%。CRc患者中，2/3未检测到MRD。达到CR/CRi的3名患者均转为HSCT，其中两名患者有移植史，所有患者在随访9、8.1和6.1个月时仍处于完全缓解状态。后续关键II期研究NCT06514794计划于2024年末开始招募，包括1岁及以上的儿童患者；在R/R患者队列的安全性得到确认后，可能会启动探索性的MRD阳性队列研究。 CD7 CAR-T治疗CD7+ T-NHL I期剂量递增和剂量扩展研究：： 5名T-NHL患者接受WU-CART-007治疗，无患者出现免疫效应细胞相关神经毒性综合征（ICANS）或GvHD，表现出可控的安全性。疗效方面：2例完全缓解（CR）；2例部分缓解（PR）；1例病情稳定（SD），显示出早期疗效迹象。本研究（NCT05377827）的招募仍在进行，以进一步确定其在CD7阳性T-NHL和AML患者中的安全性和初步疗效。 NK细胞疗法报告详情如下： 916 W-NK1 Choreographs Innate and Adaptive Immune Responses to Provide a Robust and Durable Anti-AML Response Program: Oral and Poster Abstracts Type: Oral Session: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Enhancing NK Cell Therapeutics 4257 WUN101-01: First in Human Human (FIH) Phase 1 Study of WU-NK-101 (W-NK1) in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) Program: Oral and Poster Abstracts Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III WU-NK-101已获得美国食品药品监督管理局（FDA）授予的用于治疗AML的孤儿药认证。此次会议上，Wugen将报告通用现货型NK细胞疗法的最新数据,主要亮点包括： WU-NK-101协调固有和适应性免疫应答，提供强效且持久的抗AML反应：与供体cNK细胞相比，W-NK1在NKG2A、2B4、DNAM-1以及免疫参与受体的表达上更高；W-NK1与未成熟DC共培养可增加DC的激活标志物表达；分泌的趋化因子在跨膜实验中能有效招募T细胞；W-NK1显著增强T细胞激活和增殖（P<0.01）；促肿瘤M2型巨噬细胞表现出选择性细胞毒性，显示其倾向于改善TME的免疫抑制状态。这些结果同样通过AML异种移植NCG小鼠模型（THP-1和HL-60）体内得到验证。 WU-NK-101在复发或难治性（R/R）急性髓性白血病（AML）患者中的I期研究：入组9名患者（每个剂量水平3名），表现出可管理的安全性。未报告免ICANS或GvHD；未观察到无疾病情况下的持续性全血细胞减少，也未报告剂量限制性毒性（DLT）。在DL1水平未观察到缓解，但所有患者外周血母细胞均短暂减少；在DL2及以上水平，除1例外，所有患者骨髓母细胞均减少， ORR为50%（包括2例CRi和1例PR）。摘要原文链接： 1. https://ash.confex.com/ash/2024/webprogram/Paper201520.html 2. https://ash.confex.com/ash/2024/webprogram/Paper201812.html 3. https://ash.confex.com/ash/2024/webprogram/Paper202005.html 4. https://ash.confex.com/ash/2024/webprogram/Paper201998.html 5. https://ash.confex.com/ash/2024/webprogram/Paper200809.html 关于WU-CART-007 WU-CART-007是一种通用现货型CD7靶向CAR-T细胞疗法，旨在克服利用CAR-T细胞治疗CD7+血液系统恶性肿瘤的技术挑战。Wugen利用CRISPR/Cas9基因编辑技术，删除CD7和T细胞受体恒定区（TRAC），防止CAR-T细胞自相残杀，降低移植物抗宿主病（GvHD）的风险。WU-CART-007使用健康供者来源的T细胞制备，消除在自体CAR-T环境中观察到的恶性细胞污染风险。Wugen已与合作伙伴共同开发出稳定且高效扩增的CD7 CAR-T商业化生产工艺，已完成首个I/II 期爬坡及扩展队列研究（NCT04984356）,是目前全球临床进度最快的同类通用现货型细胞产品。关于WU-NK-101 WU-NK-101是一种新型的免疫疗法，利用记忆自然杀伤细胞（NK）治疗血液和实体肿瘤。记忆NK细胞是一种功能性强、持久力高的免疫细胞，具备增强的抗肿瘤活性和细胞因子诱导的记忆样（CIML）表型。这种罕见的细胞群具有优越的表型、增殖能力和代谢适应性，与其他NK细胞疗法相比更适合用于癌症治疗。Wugen正在应用其专有的MonetaTM平台，将WU-NK-101开发为一种商业规模化、现货型的癌症细胞疗法。关于上海晨泰森豪医药科技有限公司晨泰森豪成立于2020年，是一家致力于开发临床急需的通用型细胞治疗药物的创新医疗公司。2021年1月与Wugen达成独家许可和合作协议，共同开发通用现货型记忆NK细胞和CAR-T细胞。用于治疗晚期血液瘤和实体瘤，并积极开发神经退行性疾病和自身免疫疾病的应用。晨泰森豪拥有经验丰富的医学、临床运营、药学开发、注册事务和商业化团队，通过整合肿瘤领域的专业知识，不断寻找创新解决方案，从而改善肿瘤患者的生活。关于Wugen Inc. Wugen是一家临床阶段的生物技术公司，致力于开发下一代用于治疗癌症的“现货型”免疫记忆自然杀伤 (NK) 细胞疗法和CAR-T细胞疗法。Wugen利用其专有的技术平台和深厚的基因组工程专业技术来开创一种新型的免疫记忆NK细胞和CAR-T细胞疗法，以治疗血液和实体恶性肿瘤。文章封面来源：Freepik

免疫疗法细胞疗法临床结果孤儿药优先审批

2024-11-12

·GlobeNewswire-Health Care

Wugen to Initiate a Pivotal Trial for Its Investigational, Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy, WU-CART-007, in Patients with Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia or T Cell Lymphoblastic Lymphoma

-- First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy to Begin in First Quarter 2025-- The Global Study Will Evaluate WU-CART-007 in Pediatric and Adult Patients ST. LOUIS, Mo. and SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced it will initiate a pivotal Phase 2 study in the first quarter of 2025 for the company’s potential first-in-class, investigational, anti-CD7 CAR-T cell therapy, WU-CART-007, in patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). “T-ALL/LBL is an aggressive cancer with a significant need for new therapies given that many patients will progress on standard of care,” said Kumar Srinivasan, Ph.D., Wugen president and chief executive officer. “Wugen is well positioned for this critical stage of research and development for WU-CART-007. Recently, we generated positive Phase 1/2 results; received significant new regulatory designations – RMAT and PRIME – to expedite our clinical development path in the United States and Europe; and deepened our cell therapy expertise with Cherry T. Thomas, M.D. joining our team as chief medical officer.” The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will evaluate the efficacy of WU-CART-007 in two groups: an R/R cohort and an exploratory minimum residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia. “With a 20-year void of new medicines to treat patients with relapsed or refractory T-ALL/LBL, many of whom are young, we believe off-the-shelf allogeneic CD7-targeted CAR-T cell therapies may offer hope and innovation,” said Dr. Thomas, Wugen’s chief medical officer. “Wugen’s progress in advancing WU-CART-007 also includes a robust, scalable and efficient commercial manufacturing process, developed with our partners to create a CD7-targeted therapy for off-the-shelf use,” said Matt Cooper, Ph.D., Wugen’s co-founder and chief scientific officer, who invented WU-CART-007 as a researcher at Washington University in St. Louis, MO. Wugen previously announced positive results from a Phase 1/2 cohort expansion study showing clinically manageable safety and evidence of anti-leukemic activity (overall response rate of 91%) in heavily pre-treated patients with R/R T-ALL/LBL. Researchers will present a data update at the American Society of Hematology Annual Meeting (ASH) 2024, Dec. 7-10 in San Diego. Follow Wugen’s LinkedIn page to see abstracts to be presented at ASH 2024 for WU-CART-007 and for WU-NK-101, Wugen’s investigational off-the-shelf memory natural killer cell therapy. About WU-CART-007 WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794. WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need. About Wugen Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com and follow Wugen’s LinkedIn page. Investor Contact:Mark LewisWugenMlewis@wugen.com314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com215-595-5211

细胞疗法孤儿药快速通道ASH会议临床2期

100 项与 WU-CART-007 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
难治性 T 急性淋巴细胞白血病	临床2期	中国	江苏晨泰医药科技有限公司	2024-03-29
淋巴母细胞淋巴瘤	临床2期	法国	Wugen, Inc.	2022-01-14
淋巴母细胞淋巴瘤	临床2期	荷兰	Wugen, Inc.	2022-01-14
T细胞急性淋巴细胞白血病/淋巴瘤	临床2期	法国	Wugen, Inc.	2022-01-14
T细胞急性淋巴细胞白血病/淋巴瘤	临床2期	荷兰	Wugen, Inc.	2022-01-14
成人T细胞白血病/淋巴瘤	临床1期	美国	Wugen, Inc.	2023-10-10
间变性大细胞淋巴瘤	临床1期	美国	Wugen, Inc.	2023-10-10
CD7阳性血液肿瘤	临床1期	美国	Wugen, Inc.	2023-10-10
肠病相关的T细胞淋巴瘤	临床1期	美国	Wugen, Inc.	2023-10-10
结外NK-T细胞淋巴瘤	临床1期	美国	Wugen, Inc.	2023-10-10

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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


NCT04984356 (WU-CART-007 1001, ASH2024) 人工标引	临床1/2期	T细胞急性淋巴细胞白血病/淋巴瘤 CD7 Positive	5	WU-CART-007 (WT-7)	齋網醖鑰製餘鬱鑰觸夢(襯淵鹹衊艱範衊憲觸願) = 構鏇鹹構鹽衊齋艱壓繭夢壓餘窪積廠鹹憲餘繭 (鬱觸窪壓範艱製齋襯顧 ) 更多	积极	2024-12-08
NCT05377827 (ASH2024) 人工标引	临床1期	T细胞淋巴瘤	5	WU-CART-007	餘鏇艱壓遞廠觸艱夢鑰(艱願繭範壓鬱淵範選網) = toxicities have included grade 4 neutropenia (5 patients), grade 4 thrombocytopenia (5 patients), cytokine release syndrome (grade 1 in 3 patients, grade 2 in 2 patients), 1 patient with grade 2 Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome, and 1 patient with a grade 5 opportunistic fungal infection (mucormycosis). No patients have experienced Immune Effector Cell Associated Neurotoxicity Syndrome or GvHD. 顧鏇選蓋製願願蓋醖鬱 (糧製鹹衊製鏇築夢鑰淵 )	积极	2024-12-07
NCT04984356 (Pubmed \| ) 人工标引	临床1/2期	T细胞急性淋巴细胞白血病/淋巴瘤 CD7	26	WU-CART-007 (RP2D)	簾淵糧鹽鹹鏇遞構鏇簾(範夢願繭積築窪齋簾蓋) = 蓋繭製製糧淵夢網觸窪鬱構襯廠齋蓋壓醖窪遞 (夢壓鏇築餘夢簾觸構鏇 ) 更多	积极	2024-08-05
NCT04984356 (Biospace) 人工标引	临床2期	急性淋巴细胞白血病 \| 淋巴母细胞淋巴瘤	13	WU-CART-007 RP2D	艱簾膚築遞夢築鏇廠窪(壓淵簾醖願遞鑰鹹顧選) = 鹹糧願憲顧醖製夢艱鹹餘壓鏇淵鏇膚憲壓窪鬱 (蓋憲糧鏇獵糧餘糧鬱鹹 ) 更多	积极	2024-07-14
NCT04984356 (WU-CART-007, EHA 12024 \| EHA 22024) 人工标引	临床1/2期	T细胞急性淋巴细胞白血病/淋巴瘤	13	WU-CART-007	鏇醖鏇糧顧鹹簾遞獵窪(醖觸構廠簾淵膚齋鬱遞) = 壓獵衊衊夢淵壓窪繭憲範顧鹽餘壓鏇醖築壓簾 (鏇鏇糧繭淵廠餘繭顧製 ) 更多	积极	2024-05-14
EHA2024	N/A	淋巴母细胞淋巴瘤	-	WU-CART-007 (Standard Lymphodepleting (sLD))	製積製餘鏇繭製鑰襯鬱(範簾淵膚遞築鑰願鑰構) = 簾鬱鹽簾製選願願憲壓鑰蓋艱廠選選鹽鹹範膚 (醖膚鏇醖壓構遞網鏇鹽 ) 更多	-	2024-05-14
EHA2024	N/A	淋巴母细胞淋巴瘤	-	WU-CART-007 (Enhanced Lymphodepleting (eLD))	製積製餘鏇繭製鑰襯鬱(範簾淵膚遞築鑰願鑰構) = 願醖願繭願鏇壓衊壓淵鑰蓋艱廠選選鹽鹹範膚 (醖膚鏇醖壓構遞網鏇鹽 ) 更多	-	2024-05-14
NCT04984356 (WU-CART-007 1001, ASH2023) 人工标引	临床1/2期	前体T淋巴细胞白血病淋巴瘤 \| 淋巴母细胞淋巴瘤	18	WU-CART-007	觸繭範觸選構觸簾範築(蓋廠廠製網憲構網觸選) = 淵鬱廠範糧膚窪繭築鬱襯醖壓鹹餘網築簾獵構 (鹹願齋醖製窪鬱製顧鹹 ) 更多	积极	2023-12-11