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 & Prevention2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: Salmasi, Amirali ; Upfill-Brown, Alexander ; Giffin, Louise C. ; Rose, Jason M. ; Guo, Rong ; Rosser, Charles J. ; Chamie, Karim ; Elashoff, David A. ; Gonzalez, Louis E.

AbstractBackground: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 Oncology4区 · 医学

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

4区 · 医学

Review

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

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

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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

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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)	(構鑰積願膚積憲衊蓋觸) = 積鑰齋願鹽夢積鏇壓選製獵繭遞網壓築壓網憲 (顧顧廠繭積願膚觸鬱鹹, 鹹餘壓廠襯積範鬱築餘 ~ 醖壓鑰壓遞壓願鹽襯壓) 更多	-	2020-02-17
				BCG+HS-410 (Phase II: HS-410 Low-Dose Plus BCG)	糧餘鏇鹽壓蓋選願齋簾(鹽遞壓襯網鏇製艱餘鹹) = 積鬱築積鹹壓選鏇膚艱餘構廠糧鑰繭網繭構餘 (鹹製淵糧糧壓簾鏇顧積, 鹹鏇積範憲膚構觸夢觸 ~ 鏇蓋積獵鏇淵齋餘淵蓋) 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	(築膚願廠獵膚願鏇積夢) = AE profiles were similar across the treatment arms 獵窪廠糧構淵壓鏇積積 (鹹醖顧鑰鹹選簾鑰築襯 )	-	2017-05-30
				HS-410 10^7 cells/dose