Actively Recruiting
A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation
Led by Sun Yat-sen University · Updated on 2026-01-08
9
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
I
ImmuXell Biotech Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent for HLA typing, tumor gene mutation testing, and main screening
- Male or female aged 18 to 75 years inclusive
- Pathologically or cytologically confirmed pancreatic ductal adenocarcinoma
- Unresectable locally advanced or metastatic disease with progression after prior gemcitabine-containing chemotherapy or FOLFIRINOX or NALIRIFOX regimen
- At least one measurable lesion according to RECIST 1.1 criteria
- Tumor tissue or peripheral blood positive for KRAS-G12V mutation and HLA-A*11:01 subtype
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function including specified blood counts, liver and kidney function, coagulation, heart function, and oxygen saturation
- Women of childbearing potential must have negative pregnancy test and agree to use contraception for at least 1 year after infusion; male partners must agree to use barrier contraception and avoid sperm donation for at least 1 year after infusion
You will not qualify if you...
- Other incurable malignant tumors within the past 5 years except certain treated skin basal cell cancer, carcinoma in situ, or breast cancer with no recurrence for 3 years
- History of organ transplantation
- History of mental disorders affecting compliance or consent
- History of autoimmune diseases requiring systemic immunosuppressive treatment
- Poorly controlled hypertension or recent serious heart conditions
- Symptomatic intracranial metastases
- Ascites or pleural effusion requiring recent drainage
- Tumor-related intestinal or bowel obstruction within 6 months
- Recent central nervous system disorders or autoimmune diseases involving CNS
- Positive tests for HIV, hepatitis B or C, or syphilis
- Uncontrolled infections requiring intravenous treatment
- Significant bleeding tendency or recent deep vein thrombosis unless treated and stable
- Interstitial lung disease or significant respiratory disease
- Use of certain growth factors within 2 weeks before leukapheresis
- Receipt of gene or cell therapy within 6 months
- Participation in other clinical trials within 28 days or within 5 half-lives of prior drug
- Poor compliance or contraindications to study drugs
- Need for systemic corticosteroids or immunosuppressive drugs after study starts
- Breastfeeding women unwilling to stop
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yuhong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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