Intermediate-size IND for Treatment of Patients With Advanced Cancer Using T Cells Engineered to Express TCR Targeting Mutant KRAS
Summary
The goal of this intermediate-size expanded access treatment program is to treat a subset of patients with advanced solid cancers, specifically pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), that express KRAS-G12D and the appropriate HLA with adoptive t-cell therapy. Participants will provide leukapheresis product which will be processed and generated in our facility. The participant's peripheral blood T cells will be stimulated and then transduced with GMP-grade retroviral vectors encoding KRAS-G12D-neoantigen reactive TCR. On Days -6 to -4, the participant will receive outpatient chemotherapy as a preparative regimen. On Day 0, participant will receive cell product infusion as an inpatient procedure. Following infusion, participant will receive supportive care through discharge.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TCR-T cells | Cell therapy | 1e+09 cells | — |
| Subject | TCR-T cells | Cell therapy | 1e+10 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |