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

Last updated: November 17, 2025
Sponsor: Providence Health & Services
Overall Status: Trial Not Available

Phase

N/A

Condition

N/A

Treatment

Cyclophosphamide

Gemcitabine

Cell Infusion

Clinical Study ID

NCT05389514
2020000471
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1*07:01)

Study Design

Treatment Group(s): 4
Primary Treatment: Cyclophosphamide
Phase:
Study Start date:
Estimated Completion Date:

Study 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-DRB107:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB107:01-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).