OncoMatch/Clinical Trials/NCT06898385
A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation
Is NCT06898385 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including IX001 TCR-T and Fludarabine for pancreatic cancer.
Treatment: IX001 TCR-T · Fludarabine · Cyclophosphamide — This is a single-arm, open-label clinical study to evaluate the safety, tolerability and preliminary efficacy of IX001 TCR-T injection in advanced pancreatic cancer patients with KRAS G12V mutation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: KRAS G12V
Patients with tumor tissue or peripheral blood tested positive for KRAS-G12V mutation
Required: HLA-A A*11:01 subtype (A*11:01)
expression of matching HLA-A*11:01 subtype
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: gemcitabine-containing chemotherapy (gemcitabine)
patients who have progression after prior gemcitabine-containing chemotherapy
Must have received: FOLFIRINOX (oxaliplatin, irinotecan, calcium folinate, 5-FU)
patients who have progression after prior ... FOLFIRINOX (oxaliplatin + irinotecan + calcium folinate + 5-FU)
Must have received: NALIRIFOX (irinotecan liposome, oxaliplatin, calcium folinate, 5-FU)
patients who have progression after prior ... NALIRIFOX (irinotecan liposome + oxaliplatin + calcium folinate + 5-FU)
Cannot have received: gene therapy
Receipt of gene therapy or other cell therapies within the past 6 months
Cannot have received: cell therapy
Receipt of gene therapy or other cell therapies within the past 6 months
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5×10^9/L; Platelet count ≥ 75×10^9/L; hemoglobin > 90 g/dL; Absolute lymphocyte count ≥ 0.5×10^9/L
Kidney function
Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
Liver function
Alanine aminotransferase ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastases); Aspartate aminotransferase ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastases); Serum total bilirubin ≤ 1.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion as diagnosed by echocardiography; No clinically significant electrocardiographic abnormality; Basic oxygen saturation is >92% under the indoor natural air environment
Adequate functional reserve of organs: ... see full criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify