Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether a patient's own white blood cells, genetically equipped with a T-cell receptor that recognises the KRAS G12V cancer mutation when displayed by HLA-A*11:01, can find and attack tumour cells. Chemotherapy is used first to make room for these modified cells, followed by aldesleukin to help activate them.
The idea is that targeting a mutation found in the cancer could shrink tumours while directing the immune attack more specifically than chemotherapy alone. The main measure is the proportion of patients whose tumours respond, alongside safety, rather than whether the treatment helps people live longer.
Worth knowing: This is a non-randomised trial with no comparison group, and the treatment requires cell collection, intensive chemotherapy and a prolonged hospital recovery.
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 | NCT03190941 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 110 people (planned) |
| Who can join | aged 18 Years to 72 Years |
| Run by | National Cancer Institute (NCI) |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Cyclophosphamide
- Drug Fludarabine
- Biological Anti-KRAS G12V mTCR PBL
- Drug Aldesleukin
What it is measuring
Response rate
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 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
Background:
A new cancer therapy involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. This therapy is called gene transfer using anti-KRAS G12V mTCR cells.
Objective:
To see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors.
Eligibility:
Adults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of tumors.
Design:
In another protocol, participants will:
Be screened
Have cells harvested and grown
Have leukapheresis
In this protocol, participants will have the procedures below.
Participants will be admitted to the hospital.
Over 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in the upper chest.
A few days later, participants will get the anti-KRAS G12V mTCR cells via catheter.
For up to 3 days, participants will get a drug to make the cells active.
A day after getting the cells, participants will get a drug to increase their white blood cell count. This will be a shot or injection under the skin.
Participants will recover in the hospital for 1-2 weeks. They will have lab and blood tests.
Participants will take an antibiotic for at least 6 months.
Participants will have visits every few months for 2 years, and then as determined by their doctor.
Visits will be 1-2 days.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12V
- Metastatic
- Rectal
- Colon
- Not yet treated
- Already treated
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:
- Measurable (per RECIST V1.1 criteria, metastatic, or unresectable malignancy expressing G12V mutated KRAS as assessed by one of the following methods: RT-PCR on tumor tissue, tumor DNA sequencing, or any other CLIA-certified laboratory test on resected tissue. Patients shown to have tumors expressing G12V mutated NRAS and HRAS will also be eligible as these oncogenes share complete amino acid homology with G12V mutated KRAS for their first 80 N-terminal amino acids, completely encompassing the target epitope.
- Patients must be HLA-A*11:01 positive as confirmed by the NIH Department of Transfusion Medicine.
- Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.
- Patients must have:
- previously received standard systemic therapy for their advanced cancer and have been either non-responders or have recurred, specifically:
- Patients with metastatic colorectal cancer must have had at least two systemic chemotherapy regimens that include 5FU, leucovorin, bevacizumab, oxaliplatin, and irinotecan (or similar agents), or have contraindications to receiving those medications.
- Patients with pancreatic cancer must have received gemcitabine, 5FU, and oxaliplatin (or similar agents), or have contraindications to receiving those medications.
- Patients with non-small cell lung cancer (NSCLC) must have had appropriate targeted therapy…
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 NCT03190941, registered by National Cancer Institute (NCI) 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.