Supercharged T-Cells take on Hard-to-Treat cancers
NCT ID NCT07342738
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new therapy called TCR-T cells, which are immune cells engineered to recognize and attack cancer cells with specific KRAS mutations (G12V or G12D). The study will enroll 25 adults with advanced solid tumors (like colorectal or lung cancer) who have no good treatment options left. Participants receive the engineered cells plus chemotherapy to prepare their immune system. The main goals are to check safety and see if tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TCR-T cells (engineered immune cells) plus chemotherapy drugs fludarabine and cyclophosphamide
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have specific KRAS mutations and have run out of standard therapies.
- What could go wrong
- This is a very early, small trial (25 people) focused mainly on safety. The treatment may not shrink tumors or could cause serious side effects. Success is far from guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary signing of an informed consent form (ICF); 2. Males or females, aged 18-70 years (inclusive); 3. Subjects with advanced solid tumors confirmed by histology/cytology, have failed with standard treatment, or intolerant to standard treatment, or no standard treatment exists:1)Colorectal cancer:failed or intolerant to at least two lines of standard treatment.2)Non-small cell lung cancer:Absence of the following gene mutations (Epidermal Growth Factor Receptor\[EGFR\]、Anaplastic Lymphoma Kinase\[ALK\] 、 Proto-oncogene tyrosine-protein kinase 1\[ROS1\]) and having failed or intolerant to platinum-based chemotherapy and/or immunotherapy and/or anti-angiogenic therapy.3)Other advanced solid tumors:failed with standard treatment, or intolerant to standard treatment, or no standard treatment exist. 4. At least one measurable lesion (according to Response Evaluation Criteria in Solid Tumors\[RECIST\], version 1.1); 5. Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A\*11:01 or HLA-C\*01:02 subtypes; 6. ECOG (Eastern Cooperative Oncology Group)≤2; 7. Life expectancy ≥3 months; 8. Adequate functional reserve of organs:1)Hematology (no intensive blood transfusion, platelet transfusion or cell growth factor performed within 14 days before the test):·Absolute neutrophil count ≥1×10E9/L;·Platelet count ≥50×10E9/L, hemoglobin\>90g/L;·Absolute lymphocyte count ≥0.5×10E9/L;2)Blood chemistry:·Alanine aminotransferase (ALT) ≤3×Upper Limit of Normal (ULN);·Aspartate aminotransferase (AST) ≤3×ULN(patients with hepatic metastasis, ALT and AST ≤5×ULN);·Serum creatinine ≤1.5×ULN or Creatinine clearance ≥50 mL/min;·Total bilirubin (TB) ≤1.5×ULN;3)Blood chemistry:·APTT≤1.5×ULN,INR≤1.5×ULN4)The subject has left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography;5)No clinically significant electrocardiographic abnormality;6)Basic oxygen saturation is \>92% under the indoor natural air environment. 9. Women of childbearing age must be negative for blood HCG (Human Chorionic Gonadotropin) pregnancy test (by immunofluorescence method) at screening and baseline periods, and agree to use effective contraception for at least 1 year after infusion; and male subjects whose partners are women of childbearing age must agree to use effective barrier contraception methods and avoid sperm donation for at least 1 year after infusion. Exclusion Criteria: 1. Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer); 2. History of organ transplantation; 3. A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF; 4. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease-modulating drugs; 5. Poorly controlled hypertension with drug (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart diseases within one year prior to signing the ICF; Corrected QT Interval (QTc) interval \>450 ms for males or QTc interval \>470 ms for females during screening (QTc interval calculated using the Fridericia formula); 6. Patients with intestinal obstruction or obstructive jaundice and are deemed ineligible for enrollment by the investigator; 7. Symptomatic intracranial metastases, or moderate to severe ascites or pleural effusion requiring drainage to relieve symptoms; 8. A history of or any central nervous system disorders, such as epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system within the past 6 months; 9. A positive result obtained in any of the following virological tests:1)Antibody to human immunodeficiency virus (HIV antibody); 2)Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA); 3)Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) copies ≥2000 IU/mL; 4)Treponema pallidum antibody (TP antibody) and positive for unheated serum reagin test; 10. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration; 11. Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders; 12. Deep vein thrombosis requiring treatment within the past 6 months, unless the risk of thrombosis is acceptable after treatment, as assessed by the investigator; 13. Interstitial lung disease (such as interstitial pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases at screening; 14. Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis; 15. Participation in any other clinical studies within 1 month prior to signing the master informed consent form; 16. Patients with poor compliance due to physiological, family, social, geographic and other factors, and failure to follow the study protocol and the follow-up plan; 17. Patients with contraindications to drugs used in the study; 18. Comorbidities requiring treatment with systemic corticosteroids (dexamethasone at a dose of ≥ 5 mg/day or other corticosteroids at the equivalent dose) or other immunosuppressive drugs after initiation of the study treatment, as judged by the investigator; 19. Women who are breastfeeding and are unwilling to stop breastfeeding; 20. Any other conditions that are, in the opinion of the investigator, not suitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?