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RECRUITING
NCT06043713
PHASE1

Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRASG12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in treating patients with solid tumor 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 solid cancer tumor cells.

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 Solid Tumors With KRAS G12V Mutations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-12-15

Completion Date

2028-01-01

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

DRUG

Bendamustine

Receive IV

PROCEDURE

Biopsy

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Receive IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine

Receive IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Positron Emission Tomography

Undergo PET

BIOLOGICAL

T-cell Receptor-engineered T-cells

Receive FHA11KRASG12V-TCR IV

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States