Actively Recruiting
IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
Led by Shanghai Pudong Hospital · Updated on 2024-07-05
12
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
S
Shanghai Pudong Hospital
Lead Sponsor
I
ImmuXell Biotech Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent form
- Male or female aged 18 to 70 years inclusive
- Diagnosed with advanced pancreatic or colorectal cancer after failing or not tolerating at least two standard treatments
- Have at least one measurable tumor lesion
- Tumor tissue or blood positive for KRAS-G12V or G12D mutations and matching HLA-A11, C01:02, or C*08:02 types
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- Life expectancy of at least 3 months
- Absolute neutrophil count of at least 1 x 10^9/L
- Platelet count of at least 50 x 10^9/L and hemoglobin greater than 90 g/dL
- Absolute lymphocyte count of at least 0.5 x 10^9/L
- Adequate organ function including liver enzymes not exceeding 2.5 times the upper limit, creatinine clearance of at least 60 mL/min, total serum bilirubin less than 1.5 times normal, heart function with left ventricular ejection fraction of at least 50%, no significant heart or ECG abnormalities, and oxygen saturation above 92% in room air
- Women of childbearing age must have negative pregnancy tests and agree to use effective contraception for at least one year after infusion; male participants with partners of childbearing potential must agree to use effective contraception and avoid sperm donation for at least one year after infusion
You will not qualify if you...
- Having other cancers except non-melanoma skin cancer with over 5 years disease-free, cervical carcinoma in situ, bladder cancer, or breast cancer
- History of mental disorders affecting study compliance or consent
- Poorly controlled high blood pressure or severe heart conditions within one year prior to consent
- QTc interval above 450 ms for males or 470 ms for females
- Presence of indwelling catheters or drainage tubes except central venous catheters
- History of central nervous system disorders or autoimmune diseases involving the central nervous system
- Positive tests for HIV, hepatitis C with active virus, hepatitis B infection, or syphilis without exclusion of active disease
- Active or uncontrolled infections requiring intravenous treatment
- Significant bleeding disorders or active gastrointestinal bleeding
- History of severe allergies or allergic constitution
- Autoimmune diseases requiring systemic immunosuppressive treatment within past 2 years
- Interstitial lung disease or significant respiratory disease
- History of organ transplantation
- Use of certain growth factors within 2 weeks before leukapheresis
- Prior gene or cell therapy targeting the same antigen within 6 months
- Participation in other clinical trials within 4 weeks before consent or within 5 drug half-lives
- Poor compliance or inability to follow study procedures
- Contraindications to study drugs such as cyclophosphamide, fludarabine, or IL-2
- Use of systemic corticosteroids or immunosuppressives within 12 weeks after treatment start
- Breastfeeding women unwilling to stop breastfeeding
- Any other conditions judged 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
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
M
MingHua Yu, Dr.
CONTACT
Z
ZhiGuo Long, M.D.
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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