Table 2.
Ongoing clinical trials involving CAR-T cell therapies in malignant gliomas.
| Clinical Trial ID | Trial Start Month.JJ | Phase | Tumor Entity | CAR | Application | Subject | Status | Notes |
|---|---|---|---|---|---|---|---|---|
| Locoregional delivery of CAR-T cells in glioma | ||||||||
| NCT02208362 | May 15 | I | Recurrent or refractory malignant glioma | IL13 Rα2 | Intracavitary Intraventricular | 82 | Active, not recruiting | |
| NCT02442297 | May 15 | I | Glioblastoma | HER2 | Intratumoral, Intracavitary Intraventricular | 28 | Recruiting | |
| NCT03170141 | May 17 | I/II | Glioblastoma | EGFRvIII (Original), Current: many targets | Intravenous Intratumoral | 20 | Enrolling by invitation | Lymphodepleting with Fludarabine and Cyclophosphamide |
| NCT03383978 | Dec. 17 | I | Recurrent HER2-positive glioblastoma | HER2 Natural Killer (NK) CAR | Intracranial | 30 | Recruiting | Also intraoperative injections |
| NCT03283631 | May 18 | I | EGFRvIII+ recurrent glioblastoma | EGFRvIII | Intratumoral via convection enhanced delivery | 2 | Terminated | Stereotactic radiosurgery followed by infusion of CAR-T cells |
| NCT03500991 | Jul. 18 | I | Recurrent or refractory HER2-positive CNS tumors | HER2 | Intracavitary Intraventricular | 48 | Recruiting | First results published (Vitanza et al. 2021) |
| NCT03389230 | Aug. 18 | I | Recurrent or refractory grade 3–4 glioma | HER2 | Intratumoral Intracavitary | 42 | Recruiting | Study arm with dual intratumoral and intraventricular application |
| NCT03638167 | Mar. 19 | I | EGFR-positive recurrent or refractory pediatric CNS tumors | EGFR806 | Intracavitary Intraventricular | 36 | Recruiting | Application route depends on tumor localization |
| NCT04045847 | May 19 | I | Recurrent malignant glioma | CD147 | Intracavitary Intratumoral | 31 | Recruiting | |
| NCT04003649 | Sep. 19 | I | Recurrent or refractory glioblastoma | IL13 Rα2 +/− nivolumab and ipilimumab | Intracavitary Intraventricular | 60 | Recruiting | |
| NCT04185038 | Dec. 19 | I | DIPG/DMG and recurrent or refractory pediatric CNS tumors | B7-H3 | Intracavitary Intraventricular | 90 | Recruiting | DIPG.(Diffuse Intrinsic Pontine Gliomas): ventricular application Non-DIPG: Tumor cavity |
| NCT04214392 | Jan. 20 | I | MPP2-positive recurrent or progressive glioblastoma | Chlorotoxin-derived | Intratumoral, Intracavitary Intraventricular | 36 | Recruiting | Study arm with dual intratumoral and intraventricular application |
| NCT04385173 | May 20 | I | Recurrent and refractory glioblastoma | B7-H3-targeted CAR-T cells with temozolomide | Intratumoral Intraventricular | 12 | Recruiting | Application within temozolomide cycles |
| NCT04510051 | Dec. 20 | I | Recurrent or refractory pediatric CNS tumors | IL13Rα2 | Intraventricular | 18 | Recruiting | Lymphodepleting with Fludarabine and Cyclophosphamide |
| NCT04661384 | May 21 | I | Leptomeningeal glioblastoma, ependymoma, or medulloblastoma | IL13 Rα2 | Intraventricular | 30 | Recruiting | hinge-optimized 41BB-co-stimulatory CAR truncated CD19-expressing |
| NCT04077866 | May 22 | I/II | Recurrent or refractory glioblastoma | B7-H3-targeted CAR-T cells with or without temozolomide | Intracavitary Intraventricular | 40 | Recruiting | Application within temozolomide cycles |
| Systemic delivery | ||||||||
| NCT01109095 | Oct. 10 | I | Recurrent or refractory glioblastoma | HER2 CMV-specific CAR-T cells | Intravenous | 16 | Completed | |
| NCT02209376 | Nov. 14 | I | EGFRVIII+ Glioblastoma | EGFRvIII | Intravenous | 11 | Terminated | Sponsor decision to terminate prior to completion to pursue combination therapies |
| NCT02575261 | Oct. 15 | I/II | EphA2-positive malignant glioma | EphA2 | Intravenous | 0 | Withdrawn | |
| NCT02664363 | Jul. 16 | I | Primary glioblastoma | EGFRvIII | Intravenous | 3 | Terminated | Leukapheresis pre-therapy Study funding ended |
| NCT02844062 | Jul. 16 | I | Glioblastoma | EGFRvIII | Intravenous | 20 | Recruiting/ Unknown |
Lymphodepleting with Fludarabine and Cyclophosphamide |
| NCT0293844 | Jul. 16 | I | Recurrent glioblastoma multiforme | PD-L1 | Intravenous | 20 | Recruiting/Unknown | Lymphodepleting with Fludarabine and Cyclophosphamide switch receptor modified |
| NCT03423992 | Mar. 18 | I | Recurrent malignant gliomas | EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2 | Intravenous | 100 | Recruiting | Different antigens |
| NCT03726515 | Mar. 19 | I | Newly diagnosed MGMT-unmethylated glioblastoma | EGFRvIII + pembrolizumab | Intravenous | 7 | Completed | MGMT-Unmethylated Glioblastoma |
| NCT04099797 | Feb. 20 | I | GD2-positive brain tumors | GD2 | Intravenous | 34 | Recruiting | Lymphodepleting with Fludarabine and Cyclophosphamide |
| NCT04196413 | Jun. 20 | I | Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG) | GD2 | Intravenous | 54 | Recruiting | Lymphodepleting with Fludarabine and Cyclophosphamide |
| NCT04903795 | May. 22 | I | Grade 4 malignant glioma | hEGFRvIII-CD3-biscFv Bispecific T cell engager (BRiTE) | Intravenous | 18 | No recruitment yet | with and without peripheral autologous T-cell (ACT) infusion |
| NCT05298995 | May. 22 | I | refractory pediatric CNS tumors | GD2 | Intravenous | 54 | Not yet recruiting | Lymphodepletion with conventional chemotherapeutics |
| NCT05168423 | Jun. 22 | I | EGFR-amplified glioblastoma | EGFR-IL13Ra2 | Intravenous | 18 | Not yet recruiting | Lymphodepleting with Fludarabine and Cyclophosphamide |
| NCT05353530 | Jun. 22 | I | Newly diagnosed CD70 positive and MGMT-unmethylated adult glioblastoma | CD70 | Intravenous | 18 | Not yet recruiting | CAR-T therapy after end of radiotherapy |
EGFRvIII, 
IL13 Rα2, 
HER2, 
CD147, 
B3-H7, 
Chlorotoxin-derived, 
EphA2, 
CD70.