Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Pancreatic, Colorectal and Non-Small Cell Lung Cancers With KRAS G12V Mutations

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title: Phase I Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors in Participants With Metastatic Pancreatic, Colorectal and Non-Small Cell Lung Cancers With KRAS G12V Mutations

Status Recruiting

Clinical Trial Summary

This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRAS G12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in treating patients with pancreatic, colorectal, and non-small cell lung cancers that has spread from where it first started (primary site) to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize KRAS G12V, a protein on the surface of tumor cells. These KRAS G12V-specific T cells may help the body's immune system identify and kill KRAS G12V pancreatic, colorectal, and non-small cell lung cancers' tumor cells.

Clinical Trial Description

OUTLINE: This is a dose-escalation study of FHA11KRASG12V-TCR.

Patients undergo leukapheresis prior to treatment and receive lymphodepletion chemotherapy with either cyclophosphamide intravenously (IV) and fludarabine IV on days -6, -5, -4, and -3 or bendamustine IV on days -4 and -3 at the discretion of the treating clinician and/or principal investigator (PI). Patients then receive FHA11KRASG12V-TCR IV on day 0. Patients may receive an additional FHA11KRASG12V-TCR IV infusion as soon as 28 days or up to 1 year after the first infusion. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) as well as blood sample collection and a tissue biopsy at baseline and throughout the trial.

After completion of study treatment, patients are followed up on day 56, 112, 168, 224, 280 and day 365, then long-term for up to 15 years. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Colorectal Adenocarcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Pancreatic Adenocarcinoma
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8

• NCT number: NCT06043713
• Study type: Interventional
• Source: Fred Hutchinson Cancer Center
• Contact: Fred Hutch Intake
• Phone: 206-606-1024
• Email: hutchdoc@fredhutch.org
• Status: Recruiting
• Phase: Phase 1
• Start date: December 15, 2023
• Completion date: December 31, 2025