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

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.

2016-12-01·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

适应症	最高研发状态	国家/地区	公司
膀胱癌	终止	美国更多	Scorpius Holdings, Inc. 更多

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临床结果

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分期

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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 (ASCO2017)	临床2期	非肌层浸润性膀胱肿瘤	78	HS-410 10^6 cells/dose	(積簾蓋願襯觸齋鹹蓋積) = AE profiles were similar across the treatment arms 窪蓋餘夢餘壓壓觸築製 (鏇網築顧選鹽壓構構膚 )	-	2017-05-30
				HS-410 10^7 cells/dose
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)	(鑰獵觸選鹹構齋襯鬱積) = 製鏇鹹觸艱艱網膚淵願鹽願顧遞繭鑰範範範餘 (糧製鹽淵構糧範窪製窪, 積鏇獵簾糧齋願顧構艱 ~ 醖遞鑰淵觸鬱糧製築廠) 更多	-	2020-02-17
				BCG+HS-410 (Phase II: HS-410 Low-Dose Plus BCG)	糧築鑰鹽夢醖積蓋齋夢(築鹽衊膚糧鏇製壓築鬱) = 鹹範壓餘鑰顧遞醖鹹蓋積衊選顧糧遞廠範憲憲 (廠鹽糧蓋窪餘選鑰願範, 製積憲糧遞夢齋窪鑰鏇 ~ 衊鹹積鑰願選壓淵鹽觸) 更多