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 (Sep 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
Treatments studied
Chemotherapy
Other
Cancer type
Tumor Agnostic
Biomarker criteria
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
Required: HLA-A a*11:01
HLA-A*11:01 confirmed through HLA typing at a clinically accredited laboratory
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
Participants must have progressed on or be intolerant to at least one lines of prior therapy including any targeted therapies indicated for participants with each of the tumor types eligible to enroll, as applicable
Must have received: targeted therapy
Patients with solid tumors harboring targetable molecular alterations including but not limited to EGFR mutations, ALK, ROS, NTRK fusions, microsatellite instability (MSI)-high, tumor mutational burden (TMB) high, BRAF v600 mutations, HER2 amplifications, must have been treated or refused treatment with applicable targeted therapies, as applicable
Cannot have received: solid organ transplant
Exception: Kidney transplant participants considered case-by-case with PI approval
Prior solid organ transplant or allogeneic hematopoietic stem cell transplant: Kidney transplant participants will be considered on a case-by-case basis requiring discussion with PI. Participants having had any other solid organ transplants will be excluded, as will those with any history of allogeneic hematopoietic stem cell transplant
Cannot have received: allogeneic hematopoietic stem cell transplant
Prior solid organ transplant or allogeneic hematopoietic stem cell transplant
Lab requirements
Blood counts
Absolute neutrophil count (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 upper limit of normal (ULN); Participants with suspected Gilbert syndrome may be included if total Bili > 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 other participants at discretion of treating physician
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 upper limit of normal (ULN); Participants with suspected Gilbert syndrome may be included if total Bili > 3 mg/dL but no other evidence of hepatic dysfunction; Cardiac: Participants 60 years or older: LVEF >= 35% by echocardiogram or MUGA scan within 60 days prior to enrollment; Cardiac evaluation for other participants at discretion of treating physician; Hematologic: ANC >= 1000 cells/ mm^3
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06043713 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior solid organ transplant, allogeneic hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS g12v is a required biomarker for enrollment.
Does this trial require HLA-A?
Yes, HLA-A a*11:01 is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify