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

434

Literatures (Medical) associated with Nalotimagene Carmaleucel

01 Feb 2025·Biochemical Genetics

The Combinatorial Effect of Ad-IL-24 and Ad-HSV-tk/GCV on Tumor Size, Autophagy, and UPR Mechanisms in Multiple Myeloma Mouse Model

Article

Author: Baesi, Kazem ; Abdoli, Asghar ; Irani, Shiva ; Hosseini, Seyed Younes ; Sadat, Seyed Mehdi ; Poorghobadi, Shima

Multiple myeloma is a type of malignant neoplasia whose treatment has changed over the past decade. This study aimed to investigate the effects of combination of Adenovector-carrying interleukin-24 and herpes simplex virus 1 thymidine kinase/ganciclovir on tumor growth, autophagy, and unfolded protein response mechanisms in mouse model of multiple myeloma. Six groups of mice, including Ad-HSV-tk/GCV, Ad-IL-24, Ad-HSV-tk/IL-24, Ad-GFP, and positive and negative controls, were investigated, and each group was injected every 72 h. The tumor size was measured several times. The expression of LC3B evaluated through western blotting and ASK-1, CHOP, Caspase-3, and ATF-6 genes in the UPR and apoptosis pathways were also analyzed by the quantitative polymerase chain reaction (qPCR) method. The present results showed that the injection of Ad-HSV-tk/GCV, Ad-HSV-tk/IL-24, and metformin reduced the tumor size. The expression of LC3B was significantly higher in the treatment groups and positive control groups compared to the negative control group. The expression of CHOP, caspase-3, and ATF-6 genes was significantly higher in the Ad-IL-24 group compared to the other treatment groups. Besides, the ASK-1 expression was significantly lower in the Ad-IL-24 group as compared to the other groups. Overall, the results indicated that the presence of the HSV-tk gene in the adenovectors reduced the size of tumors and induced autophagy by triggering the expression of LC3B protein. The presence of the IL-24 might affect tumor growth but not as much the therapeutic effect of HSV-tk. Furthermore, the results indicated that co-administration of IL-24 and HSV-tk had no synergistic effect on tumor size control.

01 May 2024·Oral Diseases

Effects of cancer‐associated fibroblasts deletion using HSVtk suicide system in OSCC

Article

Author: Jing, Yue ; Ye, Chuanjin ; Celentano, Antonio ; Ni, Yanhong ; Song, Yuxian ; Zhang, Xiaoxin ; Wang, Yuhan

AbstractObjectiveTo evaluate the biological characteristics of oral cancer cells co‐cultured with cancer‐associated fibroblasts (CAFs)‐HSVtk and to assess the reliability of the CAFs‐HSVtk suicide system in a co‐culture model.MethodsCAFs were lentivirus‐transfected with PCDH‐HSVtk. Ganciclovir (GCV) was added and the survival rates of the CAFs‐HSVtk were measured. In parallel with the selective elimination of CAFs, comparison was made of the effects of CAF‐HSVtk on tumor cell proliferation/migration in a CAFs‐tumor co‐cultural system. Cell death of co‐cultured oral cancer cells was evaluated by flow cytometry.ResultsQ‐PCR analysis showed that the expression of HSVtk in the CAFs‐HSVtk group was significantly higher than in the control group (p < 0.01). The survival rates of CAFs‐HSVtk with GCV were significantly reduced (p < 0.01). Following selective depletion of CAFs‐HSVtk, the growth and migration rates of oral cancer cells co‐cultured with CAFs‐HSVtk were reduced in a mixture ratio of 1:2 (p < 0.01, p < 0.01).ConclusionsEnhanced proliferation and migration rates of oral cancer cells in co‐culture were seriously impaired after deleting CAFs using the HSVtk suicide system, while oral tumor cell death was not affected. Therefore, CAFs‐HSVtk can be utilized as a valid model for CAF signature identification.

01 Apr 2024·International Journal of Radiation Oncology*Biology*Physics

A Phase 2 Study of In Situ Oncolytic Virus Therapy and Stereotactic Body Radiation Therapy Followed by Pembrolizumab in Metastatic Non-Small Cell Lung Cancer

Article

Author: Chen, Shu Hsia ; Mejia, Jaime ; Guerrero, Carlo A ; Zhang, Jun ; Zheng, Junjun ; Mathur, Sunil ; Chang, Jenny C ; Zsigmond, Eva ; Teh, Bin S ; Sun, Kai ; Butler, Edward ; Mei, Zhuyong ; Pan, Ping-Ying ; Xu, Yitian ; Guan, Jian ; Farach, Andrew ; Bernicker, Eric H

PURPOSEA phase 2 study of stereotactic body radiation therapy (SBRT) and in situ oncolytic virus therapy in metastatic non-small cell lung cancer (mNSCLC) followed by pembrolizumab (STOMP) was designed to explore the dual approach in enhancing single pembrolizumab with ADV/HSV-tk plus valacyclovir gene therapy and SBRT in mNSCLC.METHODS AND MATERIALSSTOMP is a single-arm, open-label phase 2 study. Patients with mNSCLC received intratumoral injections of ADV/HSV-tk (5 × 10¹¹ vp) and SBRT (30 Gy in 5 fractions) followed by pembrolizumab 200 mg IV every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was overall response rate (ORR) (complete response [CR] and partial response [PR]). Secondary endpoints included clinical benefit rate (CBR) (CR, PR and stable disease [SD]), progression-free survival (PFS), overall survival (OS), and safety.RESULTS28 patients were enrolled, of whom 27 were evaluated for response. The ORR was 33.3%, including 2 CR (7.4%) and 7 PR (25.9%). CBR was 70.4%. Six of eight (75.0%) patients who were immune checkpoint inhibitor (ICI) refractory derived clinical benefits. Responders had durable responses with median PFS, and OS not reached. The entire cohort had a median PFS of 7.4 months (95% CI, 5.1-9.6 months), and median OS of 18.1 months (95% CI, 15.4-20.9 months). The combination was well tolerated, with grade 3 or higher toxicity in 6 (21.4%) patients.CONCLUSIONSThe dual approach of in situ ADV/HSV-tk plus valacyclovir gene therapy and SBRT as a chemotherapy-sparing strategy to enhance the antitumor effect of pembrolizumab is a well-tolerated encouraging treatment in patients with mNSCLC.

100 Deals associated with Nalotimagene Carmaleucel

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
acute leukemia	Phase 2	Israel	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	France	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	Greece	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	Germany	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	United States	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	Lithuania	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	Portugal	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	Belgium	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	Italy	AGC Biologics SpA	12 Apr 2010
acute leukemia	Phase 2	Spain	AGC Biologics SpA	12 Apr 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

Nalotimagene Carmaleucel

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation