Table 1 Cancer clinical trials utilizing different gene therapy approachesa
ClinicalTrials.gov Identifier | Condition/disease | Gene delivery method | Treatment | Status | First posted | Sponsor |
|---|---|---|---|---|---|---|
NCT00116597 | Pancreatic cancer | Adenovirus (Replication competent) | Theragene (Ad5-yCD/mutTKSR39rep-ADP) in combination with standard chemotherapy and radiation therapy | Phase 2: Recruiting (n = 12) | February 4, 2021 | Seoul National University Bundang Hospital |
NCT04486833 | Lung Cancer | Lipid nanoparticles | Reqorsa (quaratusugene ozeplasmid, or GPX-001 is a lipid nanoparticle encapsulating a DNA plasmid with the TUSC2 tumor suppressor gene) in combination with Osimertinib | Phase 1/2: Recruiting (n = 92) | July 27, 2020 | Genprex, Inc |
NCT03603405 | Glioblastoma Multiforme (GBM) and Anaplastic Astrocytoma (AA) | Adenovirus | ADV/HSV-tk (gene therapy) | Phase 1/2: Recruiting (n = 62) | July 27, 2018 | The Methodist Hospital Research Institute |
NCT01952730 | Colorectal Cancer | Adenovirus | GVAX: Autologous, lethally irradiated colorectal cancer cells modified to produce GM-CSF | Phase 1: Recruiting (n = 15) | September 30, 2013 | Massachusetts General Hospital |
NCT02797470 | HIV-related lymphoma | Lentivirus | Autologous Hematopoietic Stem Cell (Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced) Transplantation | Phase 1/2: Recruiting (n = 18) | June 13, 2016 | AIDS Malignancy Consortium |
NCT02280811 | HPV-Associated Cancers | Retrovirus | Patient derived WBC genetically engineered to express TCR that will target the HPV-16 E6 oncoproteins constitutively expressed on HPV 16 + cancer cells | Phase 1/2: Completed (n = 12) | November 2, 2014 | National Cancer Institute (NCI) |
NCT03544723 | Solid Tumors | Adenovirus | Adenoviral p53 + immune checkpoint inhibitors in patients with recurrent or metastatic cancers | Phase 2: Recruiting (n = 40) | June 4, 2018 | MultiVir, Inc |
NCT02858310 | HPV-Associated Cancers | Retrovirus | Patient derived WBC genetically engineered to express TCR that will target the E7 proteins expressed by HPV + cancer cells | Phase 1/2: Recruiting (n = 180) | August 8, 2016 | National Cancer Institute (NCI) |
NCT02337985 | AIDS-Related Non-Hodgkin Lymphoma | Lentivirus | Chemotherapy followed by transplantation of Hematopoietic Stem/Progenitor Cells transduced with Lentivirus encoding Multiple Anti-HIV RNAs | Phase 1: Recruiting (n = 10) | January 14, 2015 | City of Hope Medical Center |
NCT03541928 | High-risk Prostate Cancer Prostate Cancer | Herpes Simplex Virus (Replication defective) | HSV-tk + valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and prostatectomy | Phase 2: Recruiting (n = 60) | May 31, 2018 | The Methodist Hospital Research Institute |
NCT04911166 | Non-small Cell Lung Cancer | Adenovirus (Replication defective) | Combination atezolizumab in combination with Interleukin-12 | Phase 1: Recruiting (n = 16) | June 2, 2021 | The Methodist Hospital Research Institute |
NCT00004038 | Breast Cancer | Adenovirus (Replication defective) | Adenovirus p53 (Ad5CMV-p53) gene in combination with chemotherapy | Phase 1: Completed (n = 20) | May 20, 2004 | National Cancer Institute (NCI) |
NCT03281382 | Metastatic Pancreatic Cancer | Adenovirus (Replication competent) | Adenovirus-mediated cytotoxic and IL-12 gene therapy (Ad5-yCD/mutTKSR39rep-hIL12) in combination with chemotherapy | Phase 1: Completed (n = 12) | September 13, 2017 | Henry Ford Health System |
NCT00583492 | Prostate Cancer | Adenovirus (Replication competent) | Replication-competent adenovirus-mediated suicide gene therapy (Ad5-yCD/mutTKSR39rep-ADP) in combination with intensity modulated radiotherapy (IMRT) | Phase 2: Completed (n = 44) | December 31, 2007 | Henry Ford Health System |
NCT02555397 | Prostate Cancer | Adenovirus (Replication competent) | Oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy (Ad5-yCD/mutTKSR39rep-hIL12) | Phase 1: Active, not recruiting (n = 15) | September 21, 2015 | Henry Ford Health System |
NCT03281382 | Metastatic Pancreatic Cancer | Adenovirus (Replication competent) | Oncolytic adenovirus mediated cytotoxic and IL-12 gene therapy (Ad5-yCD/mutTKSR39rep-hIL12) in combination with chemotherapy | Phase 1: Completed (n = 12) | September 13, 2017 | Henry Ford Health System |
NCT00005025 | Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer | Herpes Simplex Virus (Replication defective) | Herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) followed by ganciclovir | Phase 2: Unknown (n = 14–20) | May 5, 2003 | John Stoddard Cancer Center at Iowa Methodist Medical Center |
NCT00003450 | Ovarian Cancer Peritoneal Cavity Cancer | Adenovirus (Replication defective) | Intraperitoneal adenoviral p53 (Ad5CMV-p53) gene therapy | Phase 1: Completed (n = 15–20) | December 5, 2003 | University of Texas Southwestern Medical Center |
NCT02894944 | Pancreatic Cancer | Adenovirus (Replication competent) | Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) in combination with chemotherapy | Phase 1: Completed (n = 9) | September 9, 2016 | Seoul National University Hospital |
NCT01517464 | Neoplasm | Liposome | Liposomes encapsulating RB94 gene (plasmid DNA) and attached with tumor targeting anti-transferrin receptor single chain antibody fragment (TfRscFv) | Phase 1: Completed (n = 13) | January 25, 2012 | SynerGene Therapeutics, Inc |
NCT02340117 | Metastatic pancreatic cancer | Liposome | Cationic Liposomes encapsulating human WT p53 (SGT-53) used in combination with chemotherapy | Phase 2: Recruiting (n = 28) | January 16, 2015 | SynerGene Therapeutics, Inc |
NCT05062980 | Non-Small Cell Lung Cancer | Lipid nanoparticles | Reqorsa (quaratusugene ozeplasmid, or GPX-001 is a lipid nanoparticle encapsulating a DNA plasmid with the TUSC2 tumor suppressor gene) in combination with pembrolizumab (PD-1 blocking antibody) or docetaxel ± ramucirumab | Phase 1/2: Recruiting (n = 156) | September 30, 2021 | Genprex, Inc |
NCT00001328 | Brain Neoplasm Neoplasm Metastasis | Retrovirus | NIH 3T3 cell line producing retroviral vector carrying HSV-tk gene injected into the tumors and used in combination with Cytovene (Ganciclovir Sodium) | Phase 1: Completed (n = 15) | November 4, 1999 | National Institute of Neurological Disorders and Stroke (NINDS) |
NCT00505271 | Breast Cancer | Retrovirus (Replication incompetent) | Rexin-G (retroviral vector carrying a mutant form of the cyclin G1 gene) | Phase 1/2: Completed (n = 20) | July 23, 2007 | Epeius Biotechnologies |
NCT00005796 | CNS tumors | Retrovirus | Patient derived CD34 + cells transduced with retroviral vector expressing human O6-methylguanine DNA methyltransferase and reinfused into the patients along with chemotherapy | Phase 1: Completed (n = 10) | April 28, 2004 | Indiana University |
NCT02806687 | Pancreatic Adenocarcinoma | Endoscopic ultrasound guided intratumoral injection | Gene Therapy product CYL-02 with Chemotherapy (Gemcitabine) | Phase 2: Active, not recruiting (n = 68) | June 21, 2016 | University Hospital, Toulouse |
NCT04995536 | B-Cell Non-Hodgkin Lymphoma | Intratumoral needle injection | CpG-STAT3 siRNA CAS3/SS3 (CAS3/SS3) in combination with localized radiation therapy | Phase 1: Recruiting (n = 18) | August 9, 2021 |  |