A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1
- Status
- Recruiting
- Start
- 2025-03-27
- End
- 2027-09-27
- Enrollment
- 9
- Sites
- 1
- Sponsor class
- OTHER
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Detailed description · public domain (ClinicalTrials.gov) · T1
This study will enroll participants with advanced pancreatic cancer patients with KRAS G12V mutation. The study consists of screening period, leukapheresis period, lymphodepletion period, treatment period, observation period and follow-up period. A total of 9-12 evaluable patients are planned to be recruited. The study is planned to be conducted using the "3 + 3" dose escalation design in two dose groups, and a single dose of the study drug will be administered at the dose levels of 3 × 10\^9 ± 30% cells and 1 × 10\^10 ± 30% cells. Subjects will be enrolled sequentially and treated by IX001 TCR-T injection at the corresponding planned dose level. All subjects who have received IX001 TCR-T injection will be followed for safety and efficacy up to 2 years.
Intervention · public domain (ClinicalTrials.gov) · T1
Biological: IX001 TCR-T injection. IX001 TCR-T injection will be administered intravenously after lymphodepletion.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Fludarabine. Fludarabine is used for lymphodepletion.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Cyclophosphamide. Cyclophosphamide is used for lymphodepletion.
Arm · public domain (ClinicalTrials.gov) · T1
IX001 TCR-T injection (experimental): IX001 TCR-T injection targeted for KRAS mutation
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose-limiting Toxicity (DLT). Proportion of patients with DLT Time frame: 4 weeks.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Adverse Events (AEs). Incidence and severity of adverse events Time frame: 2 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Serious Adverse Events (SAEs). Incidence and severity of serious adverse events Time frame: 2 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Objective Response Rate (ORR). Time frame: 2 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Disease Control Rate (DCR). Time frame: 2 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Changes in Serum Tumor Markers compared to Baseline. Time frame: 2 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Duration of response (DOR). Time frame: 2 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Time to response (TTR). Time frame: 2 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Progression-free survival (PFS). Time frame: 2 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
Inclusion Criteria: * 1\. Voluntary signing of an informed consent form (for Human Leukocyte Antigen (HLA) typing and tumor gene mutation test, and main screening) * 2\. Males or females, aged 18-75 years (inclusive) * 3\. Patients with pathologically (histopathologically) or cytologically confirmed pancreatic ductal adenocarcinoma * 4\. Patients with unresectable locally advanced or metastatic disease who fail standard of care, i.e., patients who have progression after prior gemcitabine-containing chemotherapy or FOLFIRINOX (oxaliplatin + irinotecan + calcium folinate + 5-FU) or NALIRIFOX (irinotecan liposome + oxaliplatin + calcium folinate + 5-FU) regimen, including those who have progression within 6 months after the end of neoadjuvant/adjuvant therapy * 5\. At least one measurable lesion (according to RECIST 1.1 criteria), specifically: longest diameter of ≥10 mm for non lymph node lesions or shortest diameter of ≥15 mm for lymph node lesions (tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable, unless unequivocal progression of the lesion is demonstrated by an evidence) * 6\. Patients with tumor tissue or peripheral blood tested positive for KRAS-G12V mutation and expression of matching HLA-A\*11:01 subtype * 7\. Eastern Cooperative Oncology Group (ECOG) ≤ 1 * 8\. Life expectancy ≥3 months * 9\. Adequate functional reserve of organs: A) Hematology requirements (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): 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; B) Blood Biochemistry Requirements: Alanine aminotransferase ≤ 3 × upper limit of normal（ULN） (≤ 5 × ULN for patients with liver metastases); Aspartate aminotransferase ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastases); Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min; Serum total bilirubin ≤ 1.5 × ULN; C) Coagulation requirements: Partial thromboplastin activity time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤1.5 × ULN; D) Left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion as diagnosed by echocardiography; E) No clinically significant electrocardiographic abnormality; F) Basic oxygen saturation is \>92% under the indoor natural air environment. * 10\. Women of childbearing age must be negative for blood …
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 9 participants (estimated).