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CART-EGFR-IL13Ra2 cells · 1 trial · 1 indication
Type, frequency, severity, and attribution of adverse events
| Arm | Type | Description |
|---|---|---|
| Cohort A (Single Fixed Dose) | EXPERIMENTAL | All subjects will receive a single fixed dose of CART-EGFR-IL13Ra2 cells on Day 0 via intracerebroventricular delivery. |
| Cohort B (Repeat Cycles Following Lymphodepletion) | EXPERIMENTAL | CART-EGFR-IL13Ra2 cells will be administered via intracerebroventricular delivery in q6 week cycles of treatment, following lymphodepletion with fludarabine, cyclophosphamide, and rituximab. |
| Name | Type | Description |
|---|---|---|
| CART-EGFR-IL13Ra2 cells | DRUG | autologous T cells transduced with a bicistronic lentiviral vector containing a murine scFv targeting EGFR epitope 806 and a humanized scFv targeting IL13Ra2; both scFvs are fused to the 4-1BB and CD3ζ signaling domains. |
| Rituximab or Rituximab biosimilar | BIOLOGICAL | 375 mg/m2/day x 1 day |
| Fludarabine + Cyclophosphamide combination | DRUG | Fludarabine: 30mg/m2/day x 3 days; Cyclophosphamide: 300mg/m2/day x 3 days |
Step #1 Inclusion Criteria: 1. Signed informed consent form 2. Male or females age ≥ 18 years. 3. Patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma (as defined by WHO 2021 Classification for CNS Tumors, including that the tumor must be IDH wildtype). The tumor must also ...
CART-EGFR-IL13Ra2 cells is an investigational cell therapy being developed for the treatment of glioblastoma (GBM). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The therapy is being studied in patients with newly diagnosed GBM following initial radiotherapy.
CART-EGFR-IL13Ra2 cells is a chimeric antigen receptor T-cell therapy designed to target two antigens commonly expressed on glioblastoma cells: EGFR and IL13Ra2. By engineering T cells to recognize these targets, the therapy aims to direct the immune system against the tumor.
CART-EGFR-IL13Ra2 cells is being developed by Gilead Sciences, Inc. (NASDAQ: GILD). The company is conducting a Phase 1 clinical trial of this investigational therapy in patients with glioblastoma.
CART-EGFR-IL13Ra2 cells is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is currently recruiting participants in the United States.
CART-EGFR-IL13Ra2 cells is being evaluated in a single Phase 1 clinical trial, NCT06973096, titled 'CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy.' The trial is recruiting patients with glioblastoma in the United States and has a target enrollment of 9 participants.