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

NCT ID: NCT05389514

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: TEMPORARILY_NOT_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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).

Conditions

KRAS G12V Mutant Advanced Epithelial Cancers

Interventions

Cyclophosphamide

Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.

Intervention Type: DRUG

Gemcitabine

Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Cytoxan; Cytoxan Lyophilized; Cy; Gemzar; KEYTRUDA; MK-3475

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Other Identifiers

2020000471

Identifier Type: -

Identifier Source: org_study_id