OncoMatch/Clinical Trials/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
Is NCT06043713 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including T-cell Receptor-engineered T-cells and Bendamustine for metastatic malignant solid neoplasm.
Treatment: Bendamustine · Cyclophosphamide · Fludarabine · T-cell Receptor-engineered T-cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HLA-A A*11:01
HLA-A*11:01 confirmed through HLA typing at a clinically accredited laboratory
Required: KRAS G12V
Previously documented KRASG12V mutation in tumor or plasma cell-free deoxyribonucleic acid (cfDNA) specimens by polymerase chain reaction (PCR) or next-generation sequencing (NGS) test
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC >= 1000 cells/mm^3
Kidney function
Creatinine clearance >= 50 ml/min by CKD-EPI or 24-hour urine clearance
Liver function
Total bilirubin < 2.0 mg/dL; AST and ALT < 5x ULN; Participants with suspected Gilbert syndrome may be included if total bilirubin > 3 mg/dL but no other evidence of hepatic dysfunction
Cardiac function
Participants 60 years or older: LVEF >= 35% by echocardiogram or MUGA scan within 60 days prior to enrollment; Cardiac evaluation for others at physician discretion
Renal: Creatinine clearance >= 50 ml/min by CKD-EPI or 24-hour urine clearance; Hepatic: Total bilirubin < 2.0 mg/dL; AST and ALT < 5x ULN; Participants with suspected Gilbert syndrome may be included if total bilirubin > 3 mg/dL but no other evidence of hepatic dysfunction; Cardiac: Participants 60 years or older are required to have LVEF >= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician; Hematologic: ANC >= 1000 cells/mm^3; Nutrition: Albumin >= 3 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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