Phase I Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors in Participants With Metastatic Solid Tumors With KRAS G12V Mutations
Fred Hutchinson Cancer Center
Summary
This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRASG12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in treating patients with solid tumor cancers that has spread from where it first started (primary site) to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize KRAS G12V, a protein on the surface of tumor cells. These KRAS G12V-specific T cells may help the body's immune system identify and kill KRAS G12V solid cancer tumor cells.
Description
OUTLINE: This is a dose-escalation study of FHA11KRASG12V-TCR. Patients undergo leukapheresis prior to treatment and receive lymphodepletion chemotherapy with either cyclophosphamide intravenously (IV) and fludarabine IV on days -6, -5, and -4, or bendamustine IV on days -4 and -3 at the discretion of the treating clinician and/or principal investigator (PI). Patients then receive FHA11KRASG12V-TCR IV on day 0. Patients may receive an additional FHA11KRASG12V-TCR IV infusion as soon as 28 days or up to 1 year after the first infusion. Patients undergo echocardiography (ECHO) or multigated acq…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * LEUKAPHERESIS: Diagnosis of metastatic solid tumor * LEUKAPHERESIS: Tissue confirmation of solid tumor. Confirmation of diagnosis must be or have been performed by internal pathology review of archival biopsy material or other pathologic material at Fred Hutch/University of Washington Cancer Consortium (UWMC) * LEUKAPHERESIS: HLA-A\*11:01 confirmed through HLA typing at a clinically accredited laboratory * LEUKAPHERESIS: Previously documented KRASG12V mutation in tumor or plasma cell-free deoxyribonucleic acid (cfDNA) specimens by polymerase chain reaction (PCR) or next-…
Interventions
- DrugBendamustine
Receive IV
- ProcedureBiopsy
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- DrugCyclophosphamide
Receive IV
- ProcedureEchocardiography
Undergo ECHO
- DrugFludarabine
Receive IV
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington