RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors (NCT06545201) | Clinical Trial Compass
Not Yet RecruitingPhase 1
RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors
China30 participantsStarted 2024-08-01
Plain-language summary
At present, there is an urgent need for new drugs for kirsten rat sarcoma viral oncogene (KRAS) mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE001. Previous similar studies suggest the feasibility of T cell receptor engineered T cell therapy (TCR-T) treatment, and measures have been taken to ensure the safe administration of RE001 and the close monitoring and management of adverse events. To sum up, RE001 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects voluntarily participate in the study and sign informed consent;
. Age ≥18 years old and ≤75 years old;
. Advanced malignant solid tumors with clear pathological diagnosis;
. Standard therapies failed or cannot be tolerated or lacks effective treatments;
. Have at least one measurable lesion;
. During the trial screening period, the following two indicators must be met (the sponsor is responsible):
. ECOG score 0-1 and expected survival time greater than 6 months;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Cardiac color ultrasound shows left ventricular ejection fraction ≥50%;
Exclusion criteria
. Those who have received major surgery, conventional chemotherapy, large-area radiotherapy, immunotherapy or biological therapy anti-tumor treatment within 4 weeks before entering the trial;
. Previous use of drugs targeting KRAS G12V mutations, including previous participation in cell therapy with similar targets Cellular testing and small molecule inhibitors targeting KRAS G12V mutations, etc.;
. Allergic reactions are known to occur to any ingredient (such as dimethyl sulfoxide, cyclophosphamide, fludarabine) or structurally similar compounds treated in this trial;
. Failure to recover from adverse reactions related to previous surgery or treatment to \< Grade 2 CTCAEV5.0;
. Hypertension that remains uncontrolled after combined treatment with 2 drugs or clinically significant (such as active) Cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent form), unstable angina, congestive heart failure classified as class II or above by the New York Heart Association, or severe arrhythmia that cannot be controlled with medication or has a potential impact on study treatment; the electrocardiogram showed obvious abnormality or average QTc interval ≧ 450ms for 3 consecutive times (at least 5 minutes interval);
. Combined with other serious organic diseases and mental disorders;
. Suffering from systemic active infections requiring treatment, including but not limited to active tuberculosis, known HIV positive patients or patients with clinically active hepatitis A, B, or C include virus carriers;
. Have a history of inflammatory bowel disease and autoimmune diseases judged by the researcher to be unsuitable for this study (such as systemic lupus erythematosus, vasculitis, etc.);