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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05650749 | GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma | PHASE1 | RECRUITING | 45 | — | — | May 23, 2023 | Jan 30, 2030 | Dec 29, 2025 | 1 | United States |
The Maximum Tolerated Dose of GPC2 CAR T cells will be determined by measuring the incidence of dose limiting toxicities following administration of the product.
Assess the frequency and severity of treatment related adverse events following administration of GPC2 CAR T cells.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Arm | EXPERIMENTAL | The dose escalation arm will determine the maximum tolerated dose of GPC2 CAR T cells using a standard 3+3 trial design. |
| Dose Expansion Arm | EXPERIMENTAL | If at least one dose from the dose expansion arm is determined to be safe, additional patients will be enrolled to the dose expansion arm to preliminarily evaluate the rate of response to GPC2 CAR T cells and further characterize the safety profile of GPC2 CAR T cells. |
| Name | Type | Description |
|---|---|---|
| GPC2 CAR T cells | BIOLOGICAL | The GPC2 CAR T investigational product is comprised of autologous human T cells that have been genetically modified to express a GPC2-targeting chimeric antigen receptor (CAR) transgene. |
Neuroblastoma Inclusion Criteria: 1. Patients must be ≥ 1 year of age 2. Patients must have high-risk neuroblastoma according to COG risk classification at the time of study enrollment. Patients who were initially considered low- or intermediate-risk, but then reclassified as high-risk are also eli...