OncoMatch/Clinical Trials/NCT06487377
IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
Is NCT06487377 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies IX001 TCR-T cells for pancreatic cancer.
Treatment: IX001 TCR-T cells — 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. The study will include 4 dose groups, using a '3+3' dose escalation design.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Colorectal Cancer
Biomarker criteria
Required: KRAS G12V
Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations
Required: KRAS G12D
Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy
having failed or intolerant to at least two lines of standard of care, including metastatic tumors (having received conventional chemotherapy), recurrent tumors (having undergone surgery and adjuvant chemotherapy in the past), or locally advanced tumors with disease progression after neoadjuvant treatment
Cannot have received: gene therapy or other cell therapies with the same target
Receipt of gene therapy or other cell therapies with the same target within the past 6 months
Lab requirements
Blood counts
Absolute neutrophil count ≥1×10E9/L; Platelet count ≥50×10E9/L; hemoglobin >90g/dL; Absolute lymphocyte count ≥0.5×10E9/L
Kidney function
Creatinine clearance ≥60mL/min
Liver function
Aspartate aminotransferase ≤2.5×ULN; Aspartate transaminase ≤2.5×ULN; Total serum bilirubin ≤1.5×UNL
Cardiac function
LVEF ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography; No clinically significant electrocardiographic abnormality; QTc interval >450 ms for males or >470 ms for females during screening (QTc interval calculated using the Fridericia formula)
Adequate functional reserve of organs: Aspartate aminotransferase ≤2.5×ULN; Aspartate transaminase ≤2.5×ULN; Creatinine clearance ≥60mL/min; Total serum bilirubin ≤1.5×UNL; 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; Absolute neutrophil count ≥1×10E9/L; Platelet count ≥50×10E9/L; hemoglobin >90g/dL; Absolute lymphocyte count ≥0.5×10E9/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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