Actively Recruiting
A Prospective Study on Super Hi-TCR-T Cells Targeting Nectin4/NKG2DL/TROP2/B7H3/GPC3/FAP for the Treatment of Refractory/Relapsed Advanced Liver Cancer and Other Solid Tumors
Led by Eastern Hepatobiliary Surgery Hospital · Updated on 2025-09-03
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating super Hi-TCR-T cells targeting multiple proteins including Nectin4, NKG2DL, TROP2, B7H3, GPC3, and FAP for treating patients with advanced hepatocellular carcinoma (HCC) and other solid tumors that have not responded to prior treatments or cannot tolerate them. This prospective, single-arm clinical trial aims to assess the safety, tolerability, and effectiveness of this cell therapy, focusing on progression-free survival as a primary outcome. The study also explores quality of life, disease control rates, overall survival, and potential biomarkers related to therapy response. The treatment involves collecting peripheral blood lymphocytes from patients to prepare customized Hi-TCR-T cells targeting three selected proteins, including FAP. Patients undergo chemotherapy pretreatment with fludarabine and cyclophosphamide before receiving an intravenous infusion of these cells at a dose of 3.0 x 10^6 cells per kilogram of body weight for each target. As the disease progresses, the cell dose or target combination may be adjusted by a multidisciplinary team to improve efficacy. The study includes preparatory, recruitment and treatment, and data analysis phases spanning several months. Participants will undergo baseline assessments including physical exams, lab tests, imaging, and tumor marker evaluations before treatment. Safety monitoring occurs frequently after cell therapy at multiple time points up to 12 months, alongside efficacy evaluations at intervals up to 36 months post-treatment. Blood samples are collected periodically to study the persistence and expansion of the infused cells and their relation to disease changes. The study duration covers the treatment period plus follow-up until 12 months after the last patient's medication ends or other defined endpoints.
CONDITIONS
Brief Title
A Clinical Study of Multi-target Hi-TCR-T Cells in the Treatment of Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced hepatocellular carcinoma (HCC) that is inoperable or unsuitable for local therapy
- Disease progression or intolerance after first or second-line therapy
- Histological or clinical diagnosis of HCC according to guidelines
- At least one measurable tumor lesion according to RECIST1.1 and mRECIST
- Positive expression (>10%) of at least two targets (Nectin4, NKG2DL, TROP2, B7H3, GPC3) by immunohistochemistry
- Adequate T cell quality: at least 5 times proliferation in 3 days and >10% lentivirus transduction efficiency
- ECOG performance status score 0-2
- Child-Pugh score 6 or less
- Expected survival of at least 3 months
- No contraindications to peripheral blood mononuclear cell collection
- Organ function meeting specified hematology, biochemistry, coagulation, cardiac, pulmonary, and renal criteria
- Negative pregnancy test for women of childbearing age
- Use of effective contraception for fertile men and women during and 12 months after treatment
- Voluntary informed consent and ability to comply with follow-up
You will not qualify if you...
- Uncontrollable active infections (except HBV or HCV)
- Active central nervous system disease or symptomatic brain metastases
- Known allergies to two or more unrelated foods/drugs or chemotherapy preconditioning drugs
- Unresolved toxicities from prior antitumor therapy above grade 1
- Participation in other drug or therapy trials within 4 weeks before treatment
- Major surgery, live vaccination, or radiotherapy within specified recent periods
- Use of systemic immunosuppressive hormone therapy >10 mg/day prednisone or equivalent within 2 weeks
- Pregnant or breastfeeding women
- History of other malignancies within 5 years except certain cured cancers
- Active inflammatory bowel disease or digestive ulcers
- Positive HIV or syphilis tests
- Large symptomatic pleural effusion or ascites requiring treatment
- History of active lung diseases or tuberculosis
- Blood system diseases like leukemia, myelodysplasia, or myeloma
- Autoimmune diseases except vitiligo
- Significant bleeding or bleeding risk within 3 months
- Severe uncontrolled medical conditions including infections, heart disease, recent thromboembolism, or stroke
- Genetic diseases
- History of stem cell or organ transplant
- History of psychotropic drug abuse or mental disorders
- Other severe medical or laboratory abnormalities increasing study risks or interfering with results
- Poor compliance or conditions making participation unsuitable as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 to 18 months
Participants receive multi-target Hi-TCR-T cell therapy after baseline assessments and chemotherapy pretreatment. The therapy involves intravenous infusion of customized Hi-TCR-T cells targeting specific tumor markers.
1 baseline visit and multiple treatment visits for cell collection and transfusions
Duration - Up to 12 months after the end of treatment
Participants are regularly followed up to monitor adverse reactions, immune responses, tumor control, and safety data after treatment ends.
Regular follow-up visits scheduled throughout the follow-up period
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Navy Military Medical University
Shanghai, Yangpu District, China, 200438
Actively Recruiting
Research Team
X
Xiaofeng Zhang, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here