Actively Recruiting
Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer
Led by Changhai Hospital · Updated on 2025-12-24
30
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells.
CONDITIONS
Official Title
Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer who have received standard chemotherapy and recurrent pancreatic cancer who have had surgery and adjuvant chemotherapy
- Tumor must express KRAS G12V mutation or G12V mutation in HRAS or NRAS confirmed by DNA or RNA sequencing
- Patients must have HLA-A*11:01 allele
- Patients with brain metastases eligible if asymptomatic with fewer than 3 lesions less than 1 cm each
- Aged between 18 to 75 years
- Good clinical performance status (ECOG 0 or 1)
- Must practice birth control during study and for four months after therapy
- Seronegative for HIV antibody
- Seronegative for hepatitis B surface antigen and core antibody or HBV undetectable by QPCR
- Seronegative for hepatitis C antibody or HCV undetectable by QPCR
- Baseline blood counts: neutrophils ≥1000/mm³, white blood cells ≥3000/mm³, platelets ≥100,000/mm³, hemoglobin >8.0 g/dL
- Baseline chemistry: ALT/AST ≤3.0 x ULN, total bilirubin ≤1.5 mg/dL (or ≤3.0 mg/dL if Gilbert's Syndrome), serum creatinine ≤1.6 mg/dL
- Anticipated lifespan greater than 12 weeks
- Willing and able to comply with study procedures and follow-up
- Able to understand and sign informed consent and durable power of attorney
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Patients with primary immunodeficiency disorders such as Severe Combined Immunodeficiency Disease or HIV
- Patients with active systemic infections, coagulation disorders, or other major medical illnesses
- Patients with concurrent opportunistic infections
- Patients receiving systemic steroid therapy
- History of severe immediate allergic reactions to study medications like cyclophosphamide or fludarabine
- Patients with active coronary ischemic symptoms
- Patients currently receiving other investigational treatments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
S
Shiwei Guo, Doctor
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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