What is this study of super Hi-TCR-T cells studying for advanced hepatocellular carcinoma?

This study is evaluating a new cell therapy called super Hi-TCR-T cells for patients with advanced liver cancer that has not responded to other treatments. Researchers aim to understand how safe and effective this therapy is in controlling cancer progression. The study is sponsored by the Eastern Hepatobiliary Surgery Hospital and involves detailed monitoring of patient responses.

Who may be eligible for this advanced hepatocellular carcinoma clinical trial?

Adults aged 18 to 75 with inoperable advanced liver cancer who have tried first or second-line treatments without success or could not tolerate them may be eligible. Patients must have certain tumor markers and good performance status, and meet specific health requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced hepatocellular carcinoma clinical trial?

Study-related care, including the cell therapy and all trial visits, is provided at no cost. However, participants may have personal travel expenses that are not guaranteed to be covered. It's important to consider these potential costs when deciding to join.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID06902389

Study of Super Hi-TCR-T Cells Targeting Multiple Markers for Treating Advanced Liver Cancer and Other Solid Tumors

Led by Eastern Hepatobiliary Surgery Hospital · Updated on 2025-09-03

Participants Needed

Research Sites

13 weeks

Total Duration

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 106 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 patients 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

Age: 18Years - 75Years

All Genders

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

Research Team

Xiaofeng Zhang, Ph.D.

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Study of Super Hi-TCR-T Cells Targeting Multiple Markers for Treating Advanced Liver Cancer and Other Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria