drugset / Trial / NCT05168423
CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM
Phase 1
Active not recruiting
67 enrolled
University of Pennsylvania
Kite Pharma (a Gilead Company) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy.
Timeline
- Start
- 2023-02-24
- Primary completion
- 2039-12-19
- Completion
- 2039-12-19
Publications
- Freeburg NF, Chafamo D, Konanur Gopikrishna G, Murphy RM, Peng JJ, Parthasarathy S, Dumont S, Estrada EG, Logun MT, Sun Y, Wang X, Grover P, Rodriguez JL, Zhang DL, Park K, Fu Y, Ben Hamouda N, Hernandez-Verdin I, Lamrani L, Hicks KA, Cooper NA, Ekwegbara C, Bawden EG, Waterfall JJ, Fuentealba J, Alcantara M, Seykora JT, Prouty SM, Barrett D, Banerjee E, Cox A, Assenmacher CA, Macia C, Yin M, Carpenter EL, Ming GL, Sautes-Fridman C, Fridman WH, Tartour E, Wherry EJ, Amigorena S, Fraietta JA, Nasrallah MP, Song H, Miller TE, Bagley SJ, O'Rourke DM, Binder ZA, Alanio C, Silverbush D. The critical role of the endogenous immune compartment after CAR T cell therapy in recurrent GBM. Cell. 2026 Jun 15:S0092-8674(26)00585-4. doi: 10.1016/j.cell.2026.05.026. Online ahead of print.
- Bagley SJ, Desai AS, Fraietta JA, Silverbush D, Chafamo D, Freeburg NF, Gopikrishna GK, Rech AJ, Nabavizadeh A, Bagley LJ, Park J, Jarocha D, Martins R, Sarmiento N, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz RM, Jadlowsky JK, Mackey S, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Barrett D, Colbourn R, Nasrallah MP, Mourelatos Z, Hwang WT, Alanio C, Siegel DL, June CH, Hexner EO, Binder ZA, O'Rourke DM. Intracerebroventricular bivalent CAR T cells targeting EGFR and IL-13Ralpha2 in recurrent glioblastoma: a phase 1 trial. Nat Med. 2025 Aug;31(8):2778-2787. doi: 10.1038/s41591-025-03745-0. Epub 2025 Jun 1.
- Bagley SJ, Logun M, Fraietta JA, Wang X, Desai AS, Bagley LJ, Nabavizadeh A, Jarocha D, Martins R, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz R, Jadlowsky JK, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Sun Y, Gladney W, Barrett D, Nasrallah MP, Hwang WT, Ming GL, Song H, Siegel DL, June CH, Hexner EO, Binder ZA, O'Rourke DM. Intrathecal bivalent CAR T cells targeting EGFR and IL13Ralpha2 in recurrent glioblastoma: phase 1 trial interim results. Nat Med. 2024 May;30(5):1320-1329. doi: 10.1038/s41591-024-02893-z. Epub 2024 Mar 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CART-EGFR-IL13Ra2 Cells | Cell therapy | 5e+06 cells | Intrathecal |
| Subject | CART-EGFR-IL13Ra2 Cells | Cell therapy | 1e+07 cells | Intrathecal |
| Subject | CART-EGFR-IL13Ra2 Cells | Cell therapy | 2.5e+07 cells | Intrathecal |
| Subject | CART-EGFR-IL13Ra2 Cells | Cell therapy | 5e+07 cells | Intrathecal |