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New treatment option for Advanced Hepatocellular Carcinoma (HCC)
Official title A Clinical Study of Multi-target Hi-TCR-T Cells in the Treatment of Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06902389
What this study is testing
What is Super Hi-TCR-T cells?
Super Hi-TCR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, single-arm, open, single-center clinical trial initiated by the investigator. The principal investigators are professors Shen Feng and Zhang Xiaofeng from The Third Affiliated Hospital of Navy Military Medical University (Shanghai Eastern Hepatobiliary Surgery Hospital).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with advanced HCC who are inoperable and unsuitable for local therapy, and whose disease has progressed or cannot tolerate therapy after...
- At least one measurable lesion was present according to RECIST1.1 and mRECIST criteria;
- The expressions of Nectin4, NKG2DL, TROP2, B7H3 and GPC3 in tumor tissues were detected by immunohistochemistry in primary and metastatic specimens...
- The patient's T cell quality (pre-experimental) assessment met the criteria: at least 5 times T cell proliferation within 3 days, and at least 10%...
- ECOG performance status score of 0-2;
You likely can't join if
- Uncontrollable active infection (excluding HBV and/or HCV infections);
- active central nervous system disease, or known concomitant brain metastases with significant neurological/psychiatric symptoms assessed by MMSE;
- Known allergy to 2 or more non-similar foods/drugs, or known allergy to chemotherapy preconditioning drugs (such as cyclophosphamide, fludarabine);
- Any toxicity caused by previous antitumor therapy before chemotherapy preconditioning has not returned to grade 1 or below (CTCAE version 5.0);
- Patients who have participated in or are participating in clinical trials of other drugs/therapies within 4 weeks prior to the first administration...
- Major surgery had been performed/received within 4 weeks prior to the first administration of the study drug or had not yet recovered from the side...
See the full eligibility criteria
- Patients with advanced HCC who are inoperable and unsuitable for local therapy, and whose disease has progressed or cannot tolerate therapy after first - or second-line therapy, and who meet one of the following...
- At least one measurable lesion was present according to RECIST1.1 and mRECIST criteria;
- The expressions of Nectin4, NKG2DL, TROP2, B7H3 and GPC3 in tumor tissues were detected by immunohistochemistry in primary and metastatic specimens or in white paraffin sections of previous pathological pathology (the...
- The patient's T cell quality (pre-experimental) assessment met the criteria: at least 5 times T cell proliferation within 3 days, and at least 10% lentivirus transduction efficiency;
- ECOG performance status score of 0-2;
- Child-Pugh score ≤6;
- Expected survival time of at least 3 months;
- No contraindications to peripheral blood mononuclear cell (PBMC) collection;
- Seven days prior to the first treatment with the study drug, organ function levels must meet the following requirements: Hematology: Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count...
- Serum pregnancy test results of women of childbearing age must be negative within 7 days before the first use of the study drug; Fertile men or women with the possibility of becoming pregnant must use a highly effective...
- The people voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
- Uncontrollable active infection (excluding HBV and/or HCV infections);
- active central nervous system disease, or known concomitant brain metastases with significant neurological/psychiatric symptoms assessed by MMSE;
- Known allergy to 2 or more non-similar foods/drugs, or known allergy to chemotherapy preconditioning drugs (such as cyclophosphamide, fludarabine);
- Any toxicity caused by previous antitumor therapy before chemotherapy preconditioning has not returned to grade 1 or below (CTCAE version 5.0);
- Patients who have participated in or are participating in clinical trials of other drugs/therapies within 4 weeks prior to the first administration of the investigational drug;
- Major surgery had been performed/received within 4 weeks prior to the first administration of the study drug or had not yet recovered from the side effects of the surgery, live vaccination, and radiotherapy within 2...
- Patients who are taking systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other equivalent hormone) and continue to use within 2 weeks prior to treatment;
- Pregnant or lactating women;
- A history of other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early prostate cancer, and cervical carcinoma in situ;
- Active inflammatory bowel disease or digestive tract ulcer;
- HIV antibody or treponema pallidum antibody test results positive;
- A large amount of pleural fluid or ascites accompanied by clinical symptoms that require symptomatic treatment;
- A history of active lung disease (pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis;
- suffering from blood system diseases: leukemia, lymph nodes, myelodysplastic syndrome or myeloma;
- Except vitiligo accidental immune deficiency disease or autoimmune disease;
- Clinically significant bleeding symptoms or definite bleeding tendency occurred within 3 months before recruitment, such as cough/hemoptysis of 2.5ml or more per day, gastrointestinal bleeding, esophageal varicose veins...
- Have any clinical problems beyond your control, including but not limited to: 1) Persistent or active (severe) infection; 2) poorly controlled hypertension (persistent blood pressure \>150/90mmHg); 3) Poorly controlled...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Yangpu District, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Yangpu District, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.