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Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors
Sponsor: Providence Health & Services
Summary
This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1\*07:01).
Official title: Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-09-25
Healthy Volunteers
Not specified
Interventions
Cyclophosphamide
Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.
Gemcitabine
Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.
Pembrolizumab
Patients will receive the anti-PD-1 immune checkpoint inhibitor pembrolizumab 200 mg IV over 30 minutes on Day -1 and will be dosed every 3 weeks.
Cell Infusion
Patient's T cells will be administered at a dose of between 1 x 10\^9 to 5.0 x 10\^10 TCR-transduced lymphocytes, which is a dose of genetically modified T cells that can be safely administered and is capable of mediating tumor regression in some patients with metastatic cancers. The cells are to be infused intravenously over approximately 30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.