Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response & Clinical Activity of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)

Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1*10^7 cells) intradermal HS-410 monotherapy.

开始日期2013-12-01

申办/合作机构

Scorpius Holdings, Inc.

100 项与 Vesigenurtucel-L 相关的临床结果

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100 项与 Vesigenurtucel-L 相关的转化医学

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100 项与 Vesigenurtucel-L 相关的专利（医药）

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项与 Vesigenurtucel-L 相关的文献（医药）

2019-06-01·Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology2区 · 医学

Urinary Cytokine Profile to Predict Response to Intravesical BCG with or without HS-410 Therapy in Patients with Non–muscle-invasive Bladder Cancer

2区 · 医学

Article

作者: Rose, Jason M. ; Chamie, Karim ; Upfill-Brown, Alexander ; Guo, Rong ; Elashoff, David A. ; Rosser, Charles J. ; Salmasi, Amirali ; Giffin, Louise C. ; Gonzalez, Louis E.

Abstract:

Background::

Despite extensive research to identify biomarkers of response in patients with non–muscle-invasive bladder cancer (NMIBC), there is no biomarker to date that can serve this purpose. Herein, we report how we leveraged serial urine samples to query a panel of cytokines at varying time points in an attempt to identify predictive biomarkers of response in NMIBC.

Methods::

Serial urine samples were collected from 50 patients with intermediate- or high-risk NMIBC enrolled in a phase II study, evaluating intravesical BCG ± intradermal HS-410 therapy. Samples were collected at baseline, week 7, week 13, week 28, and at end of treatment. A total of 105 cytokines were analyzed in each sample. To predict outcome of time-to-event (recurrence or progression), univariate and multivariable Cox analyses were performed.

Results::

Fifteen patients developed recurrence and 4 patients progressed during the follow-up period. Among clinicopathologic variables, ever-smoker versus nonsmoker status was associated with an improved response rate (HR 0.38; 95% confidence interval (CI), 0.14–0.99; P = 0.04). In the most clinically relevant model, the percent change (for 100 units) of IL18-binding protein-a (HR 1.995; 95% CI, 1.16–3.44; P = 0.01), IL23 (HR 1.12; 95% CI, 1.01–1.23; P = 0.03), IL8 (HR 0.27; 95% CI, 0.07–1.08; P = 0.06), and IFNγ-induced protein-10 (HR 0.95; 95% CI, 0.91–0.99; P = 0.04) at week 13 from baseline best predicted time to event.

Conclusions::

Urinary cytokines provided additional value to clinicopathologic features to predict response to immune-modulating agents in patients with NMIBC.

Impact::

This study serves as a hypothesis-generating report for future studies to evaluate the role of urine cytokines as a predictive biomarker of response to immune treatments.

2016-12-31·Future oncology (London, England)4区 · 医学

Vesigenurtacel-L (HS-410) in The Management of High-Grade Nonmuscle Invasive Bladder Cancer

4区 · 医学

Review

作者: Schoenberg, Mark P ; Gartrell, Benjamin ; Keehn, Aryeh

Unlike other malignancies, the death rate of bladder cancer has not declined in several decades, highlighting the need for new treatment options. In the emerging era of immunotherapy, therapeutic cancer vaccines are an attractive option to cure, control and prevent cancer. Despite this, finding a feasible and efficacious vaccine platform has proven elusive across all malignancies. Vesigenurtacel-L is the first whole cell, allogeneic vaccine intended to treat high-grade, nonmuscle invasive bladder cancer. This type of vaccine technology for bladder cancer is novel, and has the potential to be both economically and logistically feasible.

100 项与 Vesigenurtucel-L 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
膀胱癌	临床2期	美国	Scorpius Holdings, Inc.	2013-12-01
非肌层浸润性膀胱肿瘤	临床2期	美国	Scorpius Holdings, Inc.	2013-12-01

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临床结果

适应症

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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


NCT02010203 (CTgov)	临床1/2期	非肌层浸润性膀胱肿瘤	104	HS-410 (Phase I: HS-410 Low Dose)	膚範觸壓範淵壓顧積積(窪遞獵淵壓蓋築積糧築) = 糧築衊積淵鏇蓋觸選壓觸膚顧膚夢繭簾壓壓繭 (醖構齋夢鏇壓鹽網遞製, 繭鬱憲築鬱願蓋蓋餘願 ~ 夢醖築憲糧糧獵艱襯築) 更多	-	2020-02-17
				BCG+HS-410 (Phase II: HS-410 Low-Dose Plus BCG)	齋壓鏇衊淵簾廠艱夢膚(齋窪獵衊淵網築鹽鑰壓) = 範蓋簾蓋淵積蓋衊憲構糧糧觸淵齋製觸淵獵夢 (構鬱糧夢蓋觸憲獵積築, 築製窪繭製壓顧艱觸積 ~ 膚淵衊襯膚製壓醖淵遞) 更多
NCT02010203 (ASCO2017)	临床2期	非肌层浸润性膀胱肿瘤	78	HS-410 10^6 cells/dose	(遞襯窪壓鏇醖糧網鹹鬱) = AE profiles were similar across the treatment arms 鬱衊獵繭網觸網顧壓窪 (餘衊獵築積積蓋壓選衊 )	-	2017-05-30
				HS-410 10^7 cells/dose