| Trial ID # | NCT02498912 |
| Phase | I |
| Drug Class | Immunotherapy: Cellular Therapy |
| Drug Name | 4H11-28z/fIL-12/EFGRt+ CAR T |
| Alternate Drug Names | 4H11-28z/fIL-12/EFGRt+ genetically-modified T cells, autologous MUC16ecto-targeting EGFR-secreting T lymphocytes |
| Drugs in Trial | 4H11-28z/fIL-12/EFGRt+ CAR T, Cyclophosphamide, Fludarabine |
| Eligible Participant | MUC16ecto+ recurrent high grade serous ovarian cancer (> 2 prior therapies) |
| Patients Enrolled | 18 |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, evaluated per RECIST |
| Efficacy | DCR: 44% (8SD, n=18) |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | IV and IP CAR T cell therapy is safe in the absence of chemotherapy, but toxicity is observed when the CAR T cells are given post-lymphodepleting chemotherapy |
| Reference | O'Cearbhaill RE et al: A phase I clinical trial of autologous chimeric antigen receptor (CAR) T cells genetically engineered to secrete IL-12 and to target the MUC16ecto antigen in patients (pts) with MUC16ecto+ recurrent high-grade serous ovarian cancer (HGSOC). SGO (2020) abstract 54 |