Overall response rate of 90% in cohort with durable responses observed; one patient remains in complete remission at 31 months
All patients were heavily pretreated/refractory to BTK inhibitors, and only one patient has started new anti-WM treatment after MB-106
Outpatient administration was allowed and found to be feasible
Currently no FDA-approved CAR-T treatments for WM
Data presented at the European Hematology Association 2024 Hybrid Congress
WORCESTER, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T-cell therapy, show a favorable safety and efficacy profile in patients with Waldenstrom macroglobulinemia ("WM"), a rare form of blood cancer. MB-106 is being developed in a collaboration between Mustang and Fred Hutch Cancer Center ("Fred Hutch") to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL").
The updated results from the single-institution Phase 1/2 clinical trial were presented during a poster session at the European Hematology Association 2024 Hybrid Congress ("EHA2024") by Brian Till, M.D., Associate Professor and physician at Fred Hutch and University of Washington.
All ten patients in the study were previously treated with Bruton's tyrosine kinase inhibitors ("BTKi"), and their disease continued to progress while on BTKi. Overall, 90% (9/10) of the patients treated with MB-106 responded to treatment, including 3 complete responses, 2 very good partial responses and 4 partial responses. In addition, 1 patient experienced stable disease. One of the patients who achieved a complete response has remained in remission for 31 months, with an immunoglobulin M (IgM) level that decreased rapidly to the normal range after treatment with MB-106 and has remained normal since. Patients had a median of nine prior lines of therapy and only one patient has started additional anti-WM treatment after being treated with MB-106. From a safety perspective, cytokine release syndrome (CRS) occurred in nine patients: five patients with grade 1 and four patients with grade 2. One patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). No grade 3 or 4 CRS or grade 2, 3 or 4 ICANS has been observed, despite dose escalation.
"We are very encouraged by the safety and efficacy data generated in WM, along with improvements in the quality of responses over time, which demonstrates MB-106 CAR T-cell expansion and persistence," said Dr. Till.
For more information on the clinical trials, please visit using the identifier NCT05360238 for the multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.
Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and its scientists may benefit financially from this work in the future.
The Company's ability to further develop the MB-106 program for hematologic malignancies is contingent upon raising a significant amount of additional funding and / or consummating a strategic partnership.
在观察到持久反应的队列中,总缓解率为90%;一名患者在31个月时仍处于完全缓解状态
所有患者都对 BTK 抑制剂进行了严重的预治疗/难治,在 MB-106 之后,只有一名患者开始了新的抗 WM 治疗
门诊管理被允许并被证明是可行的
目前没有 FDA 批准的 WM CAR-T 疗法
在欧洲血液学协会 2024 年混合大会上公布的数据
马萨诸塞州伍斯特,2024年6月17日(GLOBE NEWSWIRE)——专注于将当今细胞疗法的医学突破转化为难以治疗的癌症的潜在治疗方法的临床阶段生物制药公司野马生物公司(“野马” 或 “公司”)(纳斯达克股票代码:MBIO)今天宣布,正在进行的针对CD20的1/2期临床试验的最新数据自体CAR T细胞疗法在Waldenstrom巨球蛋白血症(“WM”)(一种罕见的血液癌)患者中显示出良好的安全性和有效性。MB-106MB-106 是野马和弗雷德·哈奇癌症中心(“弗雷德·哈奇”)合作开发的,旨在治疗复发或难治性 B 细胞非霍奇金淋巴瘤(“B-NHL”)和慢性淋巴细胞白血病(“CLL”)患者。
弗雷德·哈奇和华盛顿大学副教授兼医生布莱恩·蒂尔在欧洲血液学协会2024年混合大会(“EHA2024”)的海报发布会上公布了单一机构1/2期临床试验的最新结果。
研究中的所有十名患者之前都接受过布鲁顿的酪氨酸激酶抑制剂(“bTKI”)的治疗,在服用bTKi期间,他们的病情继续发展。总体而言,在接受 MB-106 治疗的患者中,有 90%(9/10)对治疗有反应,包括 3 种完全反应、2 种非常好的部分反应和 4 种部分反应。此外,1名患者病情稳定。其中一名获得完全缓解的患者已缓解了 31 个月,其免疫球蛋白 M (IgM) 水平在 MB-106 治疗后迅速下降至正常范围,此后一直保持正常。患者之前接受过九种治疗的中位数,只有一名患者在接受 MB-106 治疗后开始了额外的抗 WM 治疗。从安全角度来看,九名患者出现细胞因子释放综合征(CRS):五名1级患者和四名2级患者。一名患者出现了 1 级免疫效应细胞相关神经毒性综合征 (ICANS)。尽管剂量增加,但尚未观察到3级或4级CRS或2、3或4级ICANS。
蒂尔博士说:“WM生成的安全性和有效性数据,以及随着时间的推移反应质量的改善,我们深受鼓舞,这表明了 MB-106 CAR T细胞的扩展和持久性。”
有关临床试验的更多信息,请访问使用标识符 NCT05360238 进行多中心试验,使用标识符 NCT03277729 访问弗雷德·哈奇正在进行的试验。
弗雷德·哈奇的科学家在开发这些发现方面发挥了作用,弗雷德·哈奇及其科学家将来可能会从这项工作中获得经济利益。
该公司进一步发展 MB-106 血液系统恶性肿瘤计划的能力取决于筹集大量额外资金和/或完善战略合作伙伴关系。