Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer

NCT06084299 | Recruiting Phase 1

• 1 other identifier: YS-TIL-TJL01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Single-arm, open-label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocytes (TIL) infusion followed by IL-2 after a non-myeloablative(NMA) lymphodepletion preparative regimen for the treatment of patients with advanced liver cancer.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (3)

• Types and incidence of Dose-limiting toxicity (DLT) [Safety and Tolerability]

  Dose-limiting toxicity (DLT) will be collected and graded according to CTCAE v5.0

  1 month

• Types and incidence of adverse events (AEs) ,serious adverse events (SAEs) [Safety and Tolerability]

  AE will be collected and graded according to CTCAE v5.0

  Up to 24 months

• Maximum tolerated dose [Safety and Tolerability]

  Evaluate the maximum tolerated dose of TILs in patients with advanced liver cancer

  1 month

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  6 months

• Disease Control Rate (DCR)

  Up to 24 months

• Objective response rate (ORR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Treatment (autologous tumor infiltrating lymphocytes)

EXPERIMENTAL

Post-NMA lymphodepletion, patients are infused with their autologous TIL followed by IL-2 administration.

Biological: Autologous Tumor Infiltrating Lymphocytes

Interventions

Autologous Tumor Infiltrating Lymphocytes BIOLOGICAL

Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation, and extensive expansion.

Treatment (autologous tumor infiltrating lymphocytes)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects must be informed of the study before the test and voluntarily sign a written informed consent.
• Age of the patients was between 18\~70 years
• Eligible patients have histologically proven advanced liver cancer
• Eastern Cooperative Oncology Group (ECOG) performance status was 0-1
• Metastatic lesions are confirmed by PET-CT, CT, MR and/or intraoperative exploration (more than 3, at least one accessible metastasis to procure for TILs)
• Patients have at least one separate additional measurable tumour lesion according to RECIST version 1.1 standard.
• The disease has progressed after at least two previous lines of standard treatment and there is no effective treatment option available
• Adequate normal organ and marrow function were present, including absolute neutrophil count ≥ 1×10\^9/L, leukocyte count ≥ 3×10\^9/L, platelet count ≥ 75×10\^9/L, hemoglobin ≥ 80 g/L, AST and ALT ≤ 2× of upper limit of normal, Serum creatinine ≤ 1.5× upper normal limits, Serum total bilirubin ≤ 1.5× upper normal limits
• Female subjects of childbearing age must have a negative urine or serum HCG test within 7 days before cell reinfusion
• Provide at least one gram of fresh tumor tissue and 10ml of peripheral blood for whole exome sequencing and TIL isolation and culture.
• Expected survival was at least 3 months
• Child-Push liver function score grade is A within seven days before the cell reinfusion.

You may not qualify if:

• With previous or concurrent other active cancer (except carcinoma in situ that has been cured without onset within 5 years, or those that can be cured by adequate treatment)
• Patients with metastasis to Central Nervous System or brain
• Have received organ transplantation in the past
• Received major liver surgery within 4 weeks before the first administration (except liver metastases biopsy).
• Received local treatment of the liver or other parts within 4 weeks before the first administration (transcatheter arterial chemoembolization \[TACE\], transcatheter arterial embolization \[TAE\], hepatic artery infusion \[HAI\], radiotherapy, radioembolization or ablation). Subjects are not eligible to participate in the study if the above-mentioned treatment is carried out between the last dose of sorafenib or oxaliplatin-containing regimen and the first study administration.
• After CT angiography examination, there is severe arterial embolism or hepatic artery vascular variation.
• APTT or PT \>= 5 UNL, or with bleeding evidence in two months or bleeding history in prior to the clinical study, no matter how serious it is
• Active inflammation within 7 days after systemic antibiotics treatment
• Subjects who have undergone major surgery or severe trauma such as laparotomy, thoracotomy, and laparoscopic organ removal within 4 weeks before enrollment.
• Active coronary artery disease, serious or unstable angina pectoris, or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to the clinical study
• Thrombosis or embolism event within 12 months prior to the clinical study, such as cerebrovascular accident ( including TIA) or pulmonary embolism
• Congestive heart failure of NYHA \>= Class II
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml C Hepatitis, defined as HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C.
• Presence of any active, known or suspected autoimmune disease. Subjects in a stable state who do not require systemic immunosuppressive therapy are allowed, such as: type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin diseases that do not require systemic therapy (e.g., vitiligo, psoriasis disease and hair loss).
• Any interstitial lung disease, noninfectious causes of lung inflammation, or uncontrolled systemic disease (e.g. diabetes, pulmonary fibrosis, or acute pneumonia)

Sponsors & Collaborators

• Zhiyong Huang: lead
• Wuhan Elongevity Technology Co., Ltd.: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, 430000, China

RECRUITING

Related Publications (1)

• Chesney J, Lewis KD, Kluger H, Hamid O, Whitman E, Thomas S, Wermke M, Cusnir M, Domingo-Musibay E, Phan GQ, Kirkwood JM, Hassel JC, Orloff M, Larkin J, Weber J, Furness AJS, Khushalani NI, Medina T, Egger ME, Graf Finckenstein F, Jagasia M, Hari P, Sulur G, Shi W, Wu X, Sarnaik A. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. J Immunother Cancer. 2022 Dec;10(12):e005755. doi: 10.1136/jitc-2022-005755.

  PMID: 36600653 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Zhiyong Huang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tong Yuan

CONTACT

86-15071338542; Zyhuang126@126.com

Tian Xia

CONTACT

tianxia@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 16, 2023
• Study Start: May 27, 2020
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)