Table 1.
T cell clinical trials for brain tumors.
| Title/ Trial NCT | Phase | Disease | T cell product | Interventions | n | OS | Status | Reference |
|---|---|---|---|---|---|---|---|---|
| Cellular Adoptive Immunotherapy in Treating Patients with Glioblastoma Multiforme (NCT00331526) |
II | Brain and CNS tumors, newly diagnosed or recurrent glioma | PBMC derived lymphocytes grown with IL-2 (lymphokine activated killer cells) |
Biologic: 1. Aldesleukin |
86 | Median survival of 20.5 months with a 1-year survival rate of 75%) | Completed | (11) (12) |
| Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients with Glioblastoma (NCT02661282) |
I/II | Newly diagnosed CMV positive GBM |
Ex vivo expanded polyclonal CD8+ and CD4+ CMV T cells from peripheral blood of GBM patients |
Drug: 1. Dose-intensified Temozolomide |
65 (34 were screened) |
N/A | Active, not recruiting | (13) |
| Evaluation of Recovery from Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer (ERaDICATe) (NCT00693095) |
I | GBM | CMV-autologous lymphocyte transfer |
Biologic: 1. CMV-DC vaccine |
22 | N/A | Completed | (14) |
| Adoptive Cellular Therapy in Pediatric Patients with High-grade Gliomas (ACTION) (NCT03334305) |
I | GBM | Total tumor RNA primed autologous T cells |
Biologic: 1. TTRNA-DC vaccines with GM-CSF 2.Autologous Hematopoietic Stem cells (HSCs) Drug: 1. Dose-intensified Temozolomide 2.Td vaccine |
18 | N/A | Recruiting | NCT03334305 |
| Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (BRAVO) (NCT03396575) |
I | Diffuse intrinsic pontine glioma (DIPG) | Total tumor RNA primed autologous T cells |
Biologic: 1. TTRNA-DC vaccines with GM-CSF 2.Autologous hematopoietic stem cells (HSCs) Drug: 1. Cyclophosphamide + Fludarabine 2.Td vaccine |
21 | N/A | Recruiting | NCT03396575 |
| CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients with Malignant Gliomas Expressing EGFRvIII (NCT01454596) |
I/II | Recurrent GBM | A single infusion of EGFRvIII CAR T cells |
Drug: 1. Aldesleukin 2. Fludarabine 3. Cyclophosphamide |
10 | 8 | Completed | (20) |
| Genetically Modified T-cells in Treating Patients with Recurrent or Refractory Malignant Glioma (NCT02208362) |
I | Recurrent or Refractory GBM | Intratumoral Infusion of IL13R alpha 2-specific CAR T cells followed by infusions into the ventricular system | N/A | 92 | N/A | Recruiting | (21) |
| IL13Ralpha2-Targeted Chimeric Antigen Receptor (CAR) T Cells with or Without Nivolumab and Ipilimumab in Treating Patients with Recurrent or Refractory Glioblastoma (NCT 04003649) |
I | Recurrent or Refractory GBM | Intratumoral Infusion of IL13R alpha 2-specific CAR T cells followed by infusions into the ventricular system |
Drug: 1. Ipilimumab 2. Nivolumab |
60 | N/A | Recruiting | NCT 04003649 |
| CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM (NCT01109095) |
I | Recurrent GBM | Infusion of autologous CMV-specific cytotoxic T-lymphocytes genetically modified to express CAR19 targeting the HER2 molecule | N/A | 17 | 24.5 | Completed | 22 |
| 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch (GRAIN)
(NCT01822652) |
I | Relapsed or refractory Neuroblastoma | Infusion of third generation GD2-CAR (GD2-CAR3) generated from patients’ PBMC |
Drug: 1. Cyclophosphamide 2. Fludarabine 3. Pembrolizumab |
11 | 16.8 | Active, not recruiting | (41) |
| Pembrolizumab in Patients Failing to Respond to or Relapsing After CAR T Cell Therapy for Relapsed or Refractory Lymphomas (NCT02650999) |
I/II | CD19 Diffuse Large B-cell Lymphomas, Follicular Lymphomas, Mantle Cell Lymphomas |
Infusion of PBMC derived CAR T cells specific for CD19 |
Drug: Pembrolizumab |
12 | N/A | Active, not recruiting | (42) |
| Study of DC Vaccination Against Glioblastoma (NCT01567202) |
II | GBM | Infusion of DC vaccine loaded with glioblastoma stem cell-like (GSC) antigens |
Biologic: 1. DC vaccination Drug: 1. Temozolomide Radiation: 1. Radiotherapy |
43 | 13.7 | Recruiting | |
| Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery (NCT00626015) |
I | GBM | N/A |
Biologic: 1.PEP-3-KLH conjugate vaccine Drug: 1. Daclizumab 2. Temozolomide |
16 | Completed | NCT00626015 | |
| EGFRvIII CAR T Cells for Newly-Diagnosed WHO Grade IV Malignant Glioma (NCT02664363) |
I | GBM | EGFRvIII CAR T cells |
Drug: 1. Dose-intensified temozolomide |
3 | N/A | Terminated | NCT02664363 |
CMV, cytomegalovirus; DC, dendritic cells; TTRNA, Total tumor RNA; GM-CSF, Granulocyte-macrophage colony-stimulating factor; TD vaccine, tetanus; diphtheria vaccine.