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

• Conditions: KRAS G12V Mutant Advanced Epithelial Cancers

• Registration Number: NCT05389514
• Lead Sponsor: Providence Health & Services

Brief 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).

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: TEMPORARILY_NOT_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified