Table 7.
Clinical trials on immunomodulatory gene therapies for high-grade gliomas.
| # | ClinicalTrials.gov Identifier | Title | Status | Phase | Diseases | # of Pts. Enrolled | Treatment | Locations |
|---|---|---|---|---|---|---|---|---|
| 1 | NCT00031083 | Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas | Completed | I | Glioblastoma Multiforme Anaplastic Astrocytoma Oligoastrocytoma, Mixed Gliosarcoma |
12 | Genetic: Interferon-beta | USA |
| 2 | NCT02026271 | A Study of Ad-RTS-hIL-12 With Veledimex in Subjects with Glioblastoma or Malignant Glioma | Active, not recruiting | I | Glioblastoma Multiforme Anaplastic Oligoastrocytoma |
48 | Biological: Ad-RTS-hIL-12; Drug: veledimex | USA |
| 3 | NCT03679754 | Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects with Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102 | Active, not recruiting | I | Glioblastoma Multiforme | 36 | Biological: Ad-RTS-hIL-12; Drug: veledimex | USA |
| 4 | NCT03636477 | A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects with Glioblastoma; a Substudy to ATI001-102 | Active, not recruiting | I | Glioblastoma Multiforme | 21 | Biological: Ad-RTS-hIL-12 Drug: veledimexDrug: Nivolumab |
USA |
| 5 | NCT03330197 | A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects with Brain Tumors Including DIPG |
Recruiting | I/II | Pediatric Brain Tumor Diffuse Intrinsic Pontine Glioma |
45 | Biological: Ad-RTS-hIL-12 Oral Veledimex |
USA |
| 6 | NCT03866109 | A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT |
Recruiting | I/II | Glioblastoma Multiforme | 21 | Temferon | IT |
| 7 | NCT03383978 | Intracranial Injection of NK-92/5.28. z Cells in Patients with Recurrent HER2-positive Glioblastoma |
Recruiting | I | Glioblastoma Multiforme | 30 | Biological: NK-92/5.28.z | DE |
| 8 | NCT04165941 | Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma | Recruiting | I | Brain Tumor Adult | 12 | Biological: DRI cell therapy | USA |
| 9 | NCT04214392 | Chimeric Antigen Receptor (CAR) T Cells with a Chlorotoxin Tumor- Targeting Domain for the Treatment of MPP2 + Recurrent or Progressive Glioblastoma | Recruiting | I | Recurrent Glioblastoma Recurrent Malignant Glioma Recurrent WHO Grade II Glioma Recurrent WHO Grade III Glioma |
36 | Biological: Chlorotoxin (EQ)-CD28-CD3zeta-CD19t- expressing CAR T-lymphocytes |
USA |
| 10 | NCT02208362 | Genetically Modified T-cells in Treating Patients with Recurrent or Refractory Malignant Glioma | Recruiting | I | Brain and Central Nervous System Tumors | 92 | IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells; IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes | USA |
| 11 | NCT00730613 | Cellular Adoptive Immunotherapy Using Genetically Modified T-Lymphocytes in Treating Patients with Recurrent or Refractory High-Grade Malignant Glioma | Completed | I | Brain and Central Nervous System Tumors | 3 | Biological: therapeutic autologous lymphocytes Genetic: gene expression analysis | NA |
| 12 | NCT00005796 | Combination Chemotherapy Plus Gene Therapy in Treating Patients with CNS Tumors |
Completed | I | Bone Marrow Suppression Brain and Central Nervous System Tumors |
10 | Filgrastim, gene therapy, lomustine; procarbazine, vincristine sulfate | USA |
| 13 | NCT02444546 | Wild-Type Reovirus in Combination with Sargramostim in Treating Younger Patients with High-Grade Relapsed or Refractory Brain Tumors | Active, not recruiting | I | Brain and Central Nervous System Tumors | 6 | Biological: Sargramostim Biological: Wild-type Reovirus | USA |
| 14 | NCT01082926 | Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8 + Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination with Interleukin-2 | Completed | I | Brain and Central Nervous System Tumors | 6 | Biological: therapeutic allogeneic lymphocytes; Biological: aldesleukin | USA |
Ad-RTS-hIL-12: Inducible Adenoviral Vector Engineered to express IL-12; CAR: Chimeric Antigen Receptor; CNS: Central Nervous System; DE: Germany; DIPG: Diffuse Intrinsic Pontine Glioma; GBM: Glioblastoma Multiforme; HyTK: Hybromycin Thymidine Kinase; IFN: Interferon; MGMT: 0-6-Methylguanine DNA-methyltransferase; MPP2: Palmitoylated membrane protein 2; NK: Natural Killer; Pts: Patients; WHO: World Health Organisation.