Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma

NCT06463522 | Recruiting Phase 1

• 1 other identifier: KY-2024-3-48-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Tumor-infiltrating Lymphocytes

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Safety and Tolerability of Autologous Tumor-infiltrating Lymphocytes Therapy

  day0, day3, week1, week2, week4, week12, week24

Secondary Outcomes (3)

• Concentration of Total Bilirubin (TBIL, mg/dL)

  day0, day3, week1, week2, week4, week12, week24

• Child-Turcotte-Pugh(CTP) score

  day0, day3, week1, week2, week4, week12, week24

• Quality of life of patients

  day0, day3, week1, week2, week4, week12, week24

Study Arms (1)

Tumor-infiltrating Lymphocytes Therapy

EXPERIMENTAL

Autologous Tumor-infiltrating Lymphocytes Therapy, 2.0\*10\^7/Kg, single intravenous infusion.

Procedure: Autologous Tumor-infiltrating Lymphocytes

Interventions

Autologous Tumor-infiltrating Lymphocytes PROCEDURE

Autologous Tumor-infiltrating Lymphocytes, 2.0\*10\^7/Kg, single intravenous infusion.

Tumor-infiltrating Lymphocytes Therapy

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 70 years;
• Diagnosis of HCC with BCLC stage B/C;
• Anticipated survival time is longer than 3 months;
• Liver function grade Child-Pugh A or B, without hepatic encephalopathy;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• ECOG physical status 0-2;
• Laboratory tests at baseline meet the following: Absolute neutrophil count \>1.0 x 109/L; Absolute neutrophil count \>1.0 x 109/L; White blood cell count \> 2.0 x 109/L; Platelet count \> 60 x 109/L; Hgb \> 8.0 g/dL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol/L, or \< 3 times the ULN.
• Female subjects of childbearing potential must take acceptable measures to minimize the likelihood of pregnancy during the trial. Female subjects of childbearing potential must have a negative serum or urine pregnancy result within 48 hours prior to treatment;
• Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.

You may not qualify if:

• Pregnant or breastfeeding women;
• WIth HIV/AIDS infection;
• Active infection with a temperature \>38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;
• Presence of the following pre-existing or concomitant diseases: Prior diagnosis of a severe autoimmune disease requiring systemic immunosuppression (steroids) for a prolonged period of time (more than 2 months), or immune-mediated symptomatic disease; Prior diagnosis of autoimmune-induced motor neuron disease; Prior toxic epidermal necrolysis release; Subjects with any psychiatric condition, including dementia, altered mental status, which may interfere with treatment in this study; Subjects with other malignancies in the previous 5 years; Subjects with heart failure ≥ grade 2 (NYHA) or hypertension uncontrolled by standard therapy; Subjects with unstable or active peptic ulcer or gastrointestinal bleeding; Subjects with serious uncontrollable disease, as determined by the study, that may interfere with treatment in this study;
• Subjects undergoing treatment with systemic steroids;
• Subjects who have previously used immune cell therapy (CIK, DC, DC-CIK, LAK therapy) and are less than 28 days from the end of treatment to screening;
• Subjects who are allergic to cell therapy products or related drugs;
• Subjects who have previously received an organ transplant or are planning to receive an organ transplant;
• Subjects requiring anticoagulant therapy (warfarin or heparin);
• Subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

the Fifth Medical Center of PLA

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Junliang Fu, PhD, MD

  the Fifth Medical Center of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junliang Fu, PhD, MD

CONTACT

86-10-66933214; fjunliang@163.com

Fu-Sheng Wang, PhD, MD

CONTACT

86-10-66933328; fswang302@163.com

Study Design

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

Model Details: Autologous Tumor-infiltrating Lymphocytes Therapy

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-06

Locations

CN (1)