TK008: Randomized Phase III Trial of Haploidentical HCT With or Without an Add Back Strategy of HSV-Tk Donor Lymphocytes in Patients With High Risk Acute Leukemia

The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT

Start Date12 Apr 2010

Sponsor / Collaborator

AGC Biologics SpA

100 Clinical Results associated with Nalotimagene Carmaleucel

100 Translational Medicine associated with Nalotimagene Carmaleucel

100 Patents (Medical) associated with Nalotimagene Carmaleucel

Literatures (Medical) associated with Nalotimagene Carmaleucel

01 Jan 2018·American journal of cancer research

Cholangiocarcinoma: molecular imaging-guided radiofrequency hyperthermia-enhanced intratumoral herpes simplex virus thymidine kinase gene therapy.

Article

Author: Yang, Xiaoming ; Gao, Jun ; Zhang, Feng ; Shivaram, Giri ; Xiong, Fu ; Jin, Yin ; Gu, Shannon ; Weng, Qiaoyou

We investigated the feasibility of using radiofrequency hyperthermia (RFH) to enhance green fluorescent protein (GFP)/herpes simplex virus thymidine kinase (HSV-TK)/ganciclovir (GCV) gene therapy of cholangiocarcinoma. Cholangiocarcinoma cells and mice with cholangiocarcinoma were treated by (i) GFP/HSV-TK/plasmid combined with RFH at 42°C, followed by ganciclovir administration; (ii) HSV-TK alone; (iii) RFH alone; and (iv) saline. The therapeutic effects among different treatments were evaluated by bioluminescent optical imaging and ultrasound imaging. For the technical validation, GFP/HSV-TK/plasmid was intrabiliarily injected into pig common bile duct (CBD) walls using a needle-integrated balloon catheter with or without RFH enhancement. GFP gene expression was evaluated by optical imaging, which was correlated with histology. The results show that combination therapy of HSV-TK plus RFH significantly induced lower cell viabilities and decreased bioluminescence signals compared the other three groups, which were further confirmed by the tumor volume decrease with combination therapy, as measured by ultrasound imaging. Optical imaging of CBD tissues demonstrated an increased GFP expression in the group with RFH enhancement, compared that with non-RFH treatment. We concluded that intratumoral RFH can enhance the therapeutic effect of GFP/HSV-TK/plasmid on cholangiocarcinoma, which may open new avenues for effective treatment of this deadly disease.

01 Jan 2018·American journal of cancer research

Combined treatment of cholangiocarcinoma with interventional radiofrequency hyperthermia and heat shock protein promoter-mediated HSV-TK gene therapy.

Article

Author: He, Jie ; Liu, Jiaxin ; Yang, Xiaoming ; Zhou, Jiali ; Xie, Fengnan ; Zhang, Yanhua ; Sun, Jihong ; Zhou, Fei ; Jiang, Shaojie ; Zhang, Shuanglin ; Wu, Xia ; Zhu, Yali ; Luo, Jingfeng

Cholangiocarcinoma is a most lethal malignancy frequently resistant to chemotherapy. Herpes simplex virus thymidine kinase/Ganciclovir (HSV-TK/GCV) suicide gene therapy is a promising approach to treat different cancers, including cholangiocarcinoma. However drawbacks including low therapeutic gene expression and lack of precise targeted gene delivery limit the wide clinical utilization of the suicide gene therapy. We attempted to overcome these obstacles. We established the "proof-of-principle" of this concept via serial in-vitro experiments using human cholangiocarcinoma cells and then validated the new interventional oncology technique in vivo using mice harboring the same patient derived cholangiocarcinomas. Curative effects were evaluated by magnetic resonance imaging and confirmed by pathology and laboratory examinations. Intratumoral radiofrequency hyperthermia (RFH) significantly elevated the targeted expression of HSV-TK gene and further enhanced the therapeutic effects of direct intratumoral HSV-TK/GCV gene therapy, evident as the least number of survival tumor cells, smallest tumor size, and the highest apoptosis index in the combination treatment of HSV-TK plus RFH, compared to other control treatments. The novel combination of image-guided interventional oncology, RFH technology, and direct gene therapy may be valuable for the effective treatment of cholangiocarcinoma.

01 Jul 2016·Experimental and Therapeutic MedicineQ4 · MEDICINE

Dual-modality imaging demonstrates the enhanced antitumoral effect of herpes simplex virus-thymidine kinase/ganciclovir plus gemcitabine combination therapy on cholangiocarcinoma

Q4 · MEDICINE

Article

Author: Wang, Jianfeng ; Li, Xiaoling ; Li, Ang ; Jin, Mei ; Zhang, Fan

Herpes simplex virus-thymidine kinase/ganciclovir (HSV-TK/GCV) therapy is one of the most promising therapeutic strategies for the treatment of cholangiocarcinoma, which is the second most common hepatobiliary cancer. The aim of the present study was to evaluate the enhanced therapeutic effects of HSV-TK/GCV with gemcitabine on cholangiocarcinoma. QBC939 cholangiocarcinoma cells and mouse models of cholangiocarcinoma (established via tumor xenografts) received one of the following treatments: i) Gemcitabine therapy (3 µg/ml); ii) HSV-TK/GCV monotherapy; iii) HSV-TK/GCV + gemcitabine; and iv) control group, treated with phosphate-buffered saline. Cell proliferation was quantified using MTT assay and post-treatment tumor alterations were monitored using ultrasound imaging and optical imaging. For the in vitro experiments, the MTT assays demonstrated that the relative cell viabilities in the gene therapy, gemcitabine and gemcitabine + gene groups were 70.37±9.07, 52.64±8.28 and 34.21±6.63%, respectively. For the in vivo experiments, optical imaging indicated significantly decreased optical signals in the combination therapy group, as compared with the gemcitabine and gemcitabine + gene groups (1.68±0.74 vs. 2.27±0.58 and 2.87±0.82, respectively; Р<0.05). As demonstrated by ultrasound imaging, reduced tumor volumes were detected in the combination therapy group, as compared with the three control groups (114.32±17.17 vs. 159±23.74, 201.63±19.26 and 298.23±36.1 mm3, respectively; P<0.05). The results of the present study demonstrated that gemcitabine enhances the antitumoral effects of HSV-TK/GCV on cholangiocarcinoma, which may provide a novel therapeutic strategy for the management and treatment of cholangiocarcinoma using gemcitabine and gene therapy.

100 Deals associated with Nalotimagene Carmaleucel

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Indication	Highest Phase	Country/Location	Organization	Date
acute leukemia	Discovery	LT	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	IL	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	US	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	PT	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	GR	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	IT	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	BE	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	DE	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	ES	AGC Biologics SpA	12 Apr 2010
acute leukemia	Discovery	FR	AGC Biologics SpA	12 Apr 2010

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