Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether a patient’s own T cells—a type of immune cell—can be collected, genetically equipped with a high-affinity receptor for the KRAS G12V mutation, and returned to help recognise and kill cancer cells carrying that mutation. Chemotherapy drugs are used to prepare the body before the engineered cells are given.
The idea is that directing immune cells at a tumour-specific mutation could provide a way to attack metastatic cancer cells, but this phase 1 trial is mainly measuring side effects and finding a suitable dose, not proving longer survival or longer control of the cancer.
Worth knowing: This is a small, non-randomised early-phase trial, and it is limited to cancers with the KRAS G12V mutation; the record does not state whether colorectal cancer participants are analysed separately.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06043713 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 24 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Fred Hutchinson Cancer Center |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Bendamustine
- Procedure Biopsy
- Procedure Biospecimen Collection
- Procedure Computed Tomography
- Drug Cyclophosphamide
- Procedure Echocardiography
- Drug Fludarabine
- Procedure Leukapheresis
- Procedure Magnetic Resonance Imaging
- Procedure Multigated Acquisition Scan
- Procedure Positron Emission Tomography
- Biological T-cell Receptor-engineered T-cells
What it is measuring
Incidence of adverse events
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12V
- Metastatic
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- LEUKAPHERESIS: Diagnosis of metastatic solid tumor
- LEUKAPHERESIS: Tissue confirmation of solid tumor. Confirmation of diagnosis must be or have been performed by internal pathology review of archival biopsy material or other pathologic material at Fred Hutch/University of Washington Cancer Consortium (UWMC)
- LEUKAPHERESIS: HLA-A*11:01 confirmed through HLA typing at a clinically accredited laboratory
- LEUKAPHERESIS: 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
- LEUKAPHERESIS: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm, unless lymph node in which case short axis must be ≥ 15 mm. Baseline imaging (for example, diagnostic CT chest/abdomen/pelvis and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) if clinically indicated, must be obtained within 8 weeks of the first planned T cell infusion.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06043713, registered by Fred Hutchinson Cancer Center on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.