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.
在觀察到持久反應的隊列中,總緩解率爲90%;一名患者在31個月時仍處於完全緩解狀態
所有患者都對 BTK 抑制劑進行了嚴重的預治療/難治,在 MB-106 之後,只有一名患者開始了新的抗 WM 治療
門診管理被允許並被證明是可行的
目前沒有 FDA 批准的 WM CAR-T 療法
在歐洲血液學協會 2024 年混合大會上公佈的數據
馬薩諸塞州伍斯特,2024年6月17日(GLOBE NEWSWIRE)——專注於將當今細胞療法的醫學突破轉化爲難以治療的癌症的潛在治療方法的臨床階段生物製藥公司野馬生物公司(“野馬” 或 “公司”)(納斯達克股票代碼:MBIO)今天宣佈,正在進行的針對CD20的1/2期臨床試驗的最新數據自體CAR T細胞療法在Waldenstrom巨球蛋白血癥(“WM”)(一種罕見的血液癌)患者中顯示出良好的安全性和有效性。MB-106MB-106 是野馬和弗雷德·哈奇癌症中心(“弗雷德·哈奇”)合作開發的,旨在治療復發或難治性 B 細胞非霍奇金淋巴瘤(“B-NHL”)和慢性淋巴細胞白血病(“CLL”)患者。
弗雷德·哈奇和華盛頓大學副教授兼醫生布萊恩·蒂爾在歐洲血液學協會2024年混合大會(“EHA2024”)的海報發佈會上公佈了單一機構1/2期臨床試驗的最新結果。
研究中的所有十名患者之前都接受過布魯頓的酪氨酸激酶抑制劑(“bTKI”)的治療,在服用bTKi期間,他們的病情繼續發展。總體而言,在接受 MB-106 治療的患者中,有 90%(9/10)對治療有反應,包括 3 種完全反應、2 種非常好的部分反應和 4 種部分反應。此外,1名患者病情穩定。其中一名獲得完全緩解的患者已緩解了 31 個月,其免疫球蛋白 M (IgM) 水平在 MB-106 治療後迅速下降至正常範圍,此後一直保持正常。患者之前接受過九種治療的中位數,只有一名患者在接受 MB-106 治療後開始了額外的抗 WM 治療。從安全角度來看,九名患者出現細胞因子釋放綜合徵(CRS):五名1級患者和四名2級患者。一名患者出現了 1 級免疫效應細胞相關神經毒性綜合徵 (ICANS)。儘管劑量增加,但尚未觀察到3級或4級CRS或2、3或4級ICANS。
蒂爾博士說:“WM生成的安全性和有效性數據,以及隨着時間的推移反應質量的改善,我們深受鼓舞,這表明了 MB-106 CAR T細胞的擴展和持久性。”
有關臨床試驗的更多信息,請訪問使用標識符 NCT05360238 進行多中心試驗,使用標識符 NCT03277729 訪問弗雷德·哈奇正在進行的試驗。
弗雷德·哈奇的科學家在開發這些發現方面發揮了作用,弗雷德·哈奇及其科學家將來可能會從這項工作中獲得經濟利益。
該公司進一步發展 MB-106 血液系統惡性腫瘤計劃的能力取決於籌集大量額外資金和/或完善戰略合作伙伴關係。