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New treatment option for Pancreatic Cancer
Official title IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
ClinicalTrials.gov ID: NCT06487377
What this study is testing
What is IX001 TCR-T cells?
IX001 TCR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal cancer induced by KRAS (Kirsten Rat Sarcoma Viral Oncogene) mutations. A total of 6-18 evaluable patients are planned to be enrolled.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Voluntary signing of an informed consent form (ICF);
- Males or females, aged 18-70 years (inclusive);
- Pathologically diagnosed with advanced pancreatic cancer or colorectal cancer, having failed or intolerant to at least two lines of standard of care...
- At least one measurable lesion (according to RECIST1.1[The Response Evaluation Criteria In Solid Tumors] criteria);
- Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A\ 11, C\ 01:02, or C\...
You likely can't join if
- Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder...
- A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;
- Poorly controlled hypertension with drug (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg) or occurrence of grade III-IV...
- Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, indwelling catheter, bile drainage tube or...
- A history of or any central nervous system disorders, such as epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease...
- A positive result obtained in any of the following virological tests:
See the full eligibility criteria
Who can join
- Voluntary signing of an informed consent form (ICF);
- Males or females, aged 18-70 years (inclusive);
- Pathologically diagnosed with advanced pancreatic cancer or colorectal cancer, having failed or intolerant to at least two lines of standard of care, including metastatic tumors (having received conventional...
- At least one measurable lesion (according to RECIST1.1[The Response Evaluation Criteria In Solid Tumors] criteria);
- Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A\ 11, C\ 01:02, or C\ 08:02 subtypes;
- ECOG (Eastern Cooperative Oncology Group)≤2;
- Life expectancy ≥3 months;
- Absolute neutrophil count ≥1×10E9/L;
- Platelet count ≥50×10E9/L, hemoglobin\>90g/dL;
- Absolute lymphocyte count ≥0.5×10E9/L;
- Adequate functional reserve of organs:
- Aspartate aminotransferase ≤2.5×ULN (upper limit of normal);
- Aspartate transaminase ≤2.5×ULN;
- Creatinine clearance ≥60mL/min;
- Total serum bilirubin ≤1.5×UNL;
- The subject has left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography;
- No clinically significant electrocardiographic abnormality;
- Basic oxygen saturation is \>92% under the indoor natural air environment.
- 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...
What rules you out
- 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);
- A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;
- Poorly controlled hypertension with drug (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent...
- Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, indwelling catheter, bile drainage tube or pleural/peritoneal/pericardial catheter), except any dedicated central venous...
- 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;
- A positive result obtained in any of the following virological tests:
- Antibody to human immunodeficiency virus (HIV antibody);
- Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA);
- 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;
- Treponema pallidum antibody (TP antibody); patients may be enrolled after additional examinations are performed to exclude active syphilis where necessary;
- Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration;
- Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders;
- Patients with a history of severe allergy or allergic constitution;
- A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease-modulating drugs in the past 2 years;
- Interstitial lung disease (such as pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases during screening;
- History of organ transplantation;
- Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis;
- Receipt of gene therapy or other cell therapies with the same target within the past 6 months;
- Participation in any other clinical trial within 4 weeks prior to signing the informed consent form, or the date of signing the informed consent form still within 5 half-lives of the drug from the last dose in the last...
- 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;
- Patients with contraindications to cyclophosphamide, fludarabine, IL-2, or other drugs related to the study treatment;
- 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 within 12 weeks after the study...
- Women who are breastfeeding and are unwilling to stop breastfeeding;
- Any other conditions that are, in the opinion of the investigator, not suitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.