Results of the phase I open label clinical trial SAKK 06/14 assessing safety of intravesical instillation of VPM1002BC, a recombinant mycobacterium Bacillus Calmette Guerin (BCG), in patients with non-muscle invasive bladder cancer and previous failure of conventional BCG therapy

被引：24

作者：

Rentsch, Cyrill A. ^{[1
]}

Bosshard, Piet ^{[1
,2
]}

Mayor, Gregoire ^{[3
]}

Rieken, Malte ^{[1
]}

Puschel, Heike ^{[1
]}

Wirth, Gregory ^{[3
]}

Cathomas, Richard ^{[4
]}

Parzmair, Gerald P. ^{[5
]}

Grode, Leander ^{[5
]}

Eisele, Bernd ^{[5
]}

Sharma, Hitt ^{[6
]}

Gupta, Manish ^{[6
]}

Gairola, Sunil ^{[6
]}

Shaligram, Umesh ^{[6
]}

Goldenberger, Daniel ^{[7
]}

Spertini, Francois ^{[8
]}

Audran, Regine ^{[8
]}

Enoiu, Milica ^{[9
]}

Berardi, Simona ^{[9
]}

Hayoz, Stefanie ^{[9
]}

Wicki, Andreas ^{[10
]}

机构：

[1] Univ Basel, Univ Basel Hosp, Dept Urol, Basel, Switzerland

[2] Univ Bern, Univ Hosp Bern, Dept Urol, Bern, Switzerland

[3] Univ Geneva, Univ Hosp Geneva, Dept Urol, Geneva, Switzerland

[4] Cantonal Hosp Chur, Dept Oncol, Chur, Switzerland

[5] Vakzine Projekt Management GmbH, Hannover, Germany

[6] Serum Inst India Pvt Ltd, Pune, Maharashtra, India

[7] Univ Basel, Univ Basel Hosp, Dept Clin Bacteriol & Mycol, Basel, Switzerland

[8] Lausanne Univ Hosp, Div Immunol & Allergy, Lausanne, Switzerland

[9] SAKK Coordinating Ctr, Bern, Switzerland

[10] Univ Basel, Univ Basel Hosp, Dept Oncol, Basel, Switzerland

来源：

ONCOIMMUNOLOGY | 2020年 / 9卷 / 01期

关键词：

NMIBC (Non-muscle-invasive bladder cancer); BCG-failure; clinical trial; GMO (genetically modified organism); listeriolysin; TUBERCULOSIS; METAANALYSIS; NEUTROPHILS; PROGRESSION; TRAIL; TUMOR; RISK; TNF;

D O I：

10.1080/2162402X.2020.1748981

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: VPM1002BC is a modified mycobacterium Bacillus Calmette Gue rin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC). The genetic modifications are expected to result in better immunogenicity and less side effects. We report on patient safety and immunology of the first intravesical application of VPM1002BC in human. Methods: Six patients with BCG failure received a treatment of 6 weekly instillations with VPM1002BC. Patients were monitored for adverse events (AE), excretion of VPM1002BC and cytokines, respectively. Results: No DLT (dose limiting toxicity) occurred during the DLT-period. No grade >= 3 AEs occurred. Excretion of VPM1002BC in the urine was limited to less than 24 hours. Plasma levels of TNF alpha significantly increased after treatment and blood-derived CD4+ T cells stimulated with PPD demonstrated significantly increased intracellular GM-CSF and IFN expression. Conclusion: The intravesical application of VPM1002BC is safe and well tolerated by patients and results in a potential Th1 weighted immune response.

引用

页数：8

共 35 条

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