Actively Recruiting
TCR-T Cell Therapy on Advanced Solid Tumors
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-09-08
18
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary aim of this study is to evaluate the efficacy of KRAS mutant antigen specific TCR-T cells in the treatment of patients with advanced solid tumors. The secondary aim is to evaluate the pharmacokinetic/pharmacodynamic characteristics of TCR-T cell therapy in patients with advanced solid tumors and the survival of TCR-T cells. The investigators will evaluate the changes of tumor microenvironment after treatment of advanced solid tumors with KRAS mutant antigen specific TCR-T cells; Evaluating the correlation between cytokines and the occurrence of CRS and neurotoxicity
CONDITIONS
Official Title
TCR-T Cell Therapy on Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years old
- Diagnosed advanced solid tumors confirmed by histology or cytology with failed, intolerant, or no standard treatment options
- Specific criteria for tumor types: recurrent/metastatic non-small cell lung cancer treated previously with chemotherapy or immunotherapy; pancreatic cancer failed at least one prior therapy; colorectal cancer failed at least two prior therapies; other solid tumors failed standard treatment
- Confirmed KRAS G12V or G12D mutations with matching HLA subtypes
- Expected survival of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) score 2 or lower
- Voluntary participation with signed informed consent and ability to comply with follow-up
- At least one measurable lesion per RECIST v1.1
- Female participants not pregnant or lactating, negative pregnancy test within 72 hours before enrollment, and use of accepted contraception during and for 3 months after the study
- Good organ and bone marrow function with specific blood count and biochemistry thresholds including neutrophils, lymphocytes, platelets, hemoglobin, bilirubin, creatinine, liver enzymes, and coagulation function
You will not qualify if you...
- Presence of intracranial metastasis or moderate/severe hydrothorax requiring drainage
- Active pulmonary tuberculosis
- Positive for HIV
- Active hepatitis B or C infection
- Pregnancy or lactation
- History or current other malignant tumors except certain treated skin or cervical cancers
- Central nervous system metastases
- Serious uncontrolled medical conditions or comorbidities affecting study compliance or safety
- Significant respiratory diseases affecting lung function
- Active autoimmune diseases requiring steroids or immunosuppressive therapy above specified doses
- History of organ transplantation
- Recent myocardial infarction or severe arrhythmia within 6 months, uncontrolled cardiovascular diseases
- History of psychotropic drug abuse or psychiatric disorders
- Allergies or sensitivities to study drugs including human serum albumin, cyclophosphamide, fludarabine, or interleukin-2
- Bleeding or thromboembolic disorders or recent significant bleeding events
- Other severe acute or chronic illnesses judged by investigators to increase risk or interfere with study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
M
Meng Zhang, MD
CONTACT
Z
Zhifen Zeng, MD
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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