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 (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06898385 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy, cell therapy disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS G12V is a required biomarker for enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*11:01 subtype is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualifyRelated pages