NCT05389514

Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors

Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells

• Status: Temporarily Not Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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).

Detailed description

This study will treat two identified patients with metastatic pancreatic adenocarcinoma and metastatic pancreatic cancer who have both been treated with standard of care therapies and found to have disease progression. Both of these patients have KRAS G12V mutations in their cancers and express the HLA-DRB1\*07:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB1\*07:01-restricted KRAS G12V reactive T-cell receptors (TCR). Adoptive T-cell therapy is a type of immunotherapy which involves isolation of T cells from a patient, followed by an amplification of those T cells in the lab to large numbers, and reinfusion of the T cells back to the patient. In addition to the two identified patients, the protocol will remain open for additional participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (DRB1\*07:01).

Conditions

• KRAS G12V Mutant Advanced Epithelial Cancers

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.
DRUG	Gemcitabine	Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.
DRUG	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.
BIOLOGICAL	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.

Timeline

• First posted: 2022-05-25
• Last updated: 2025-11-20