NCT06043713View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

December 15, 2023

Primary Completion Date

February 9, 2026

Study Completion Date

February 9, 2026

Conditions
Metastatic Malignant Solid Neoplasm
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

Trial Locations (1)

98109

Fred Hutch/University of Washington Cancer Consortium, Seattle

Sponsors
All Listed Sponsors
collaborator

Affini-T Therapeutics, Inc.

INDUSTRY

lead

Fred Hutchinson Cancer Center

OTHER

NCT06043713 - 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 | Biotech Hunter | Biotech Hunter