Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06973096 | CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy | PHASE1 | RECRUITING | 9 | — | — | Jul 18, 2025 | Jul 1, 2042 | May 11, 2026 | 1 | United States |
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 ...