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

NCT ID: NCT06463522

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tumor-infiltrating Lymphocytes Therapy

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

Group Type: EXPERIMENTAL

Autologous Tumor-infiltrating Lymphocytes

Intervention Type: PROCEDURE

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

Interventions

Autologous Tumor-infiltrating Lymphocytes

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 70 years;

2. Diagnosis of HCC with BCLC stage B/C;

3. Anticipated survival time is longer than 3 months;

4. Liver function grade Child-Pugh A or B, without hepatic encephalopathy;

5. Left ventricular ejection fraction (LVEF) ≥ 50%;

6. ECOG physical status 0-2;

7. 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.

8. 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;

9. Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.

Exclusion Criteria

1. Pregnant or breastfeeding women;

2. WIth HIV/AIDS infection;

3. Active infection with a temperature >38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;

4. 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;

5. Subjects undergoing treatment with systemic steroids;

6. 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;

7. Subjects who are allergic to cell therapy products or related drugs;

8. Subjects who have previously received an organ transplant or are planning to receive an organ transplant;

9. Subjects requiring anticoagulant therapy (warfarin or heparin);

10. Subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junliang Fu, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

the Fifth Medical Center of PLA

Locations

the Fifth Medical Center of PLA

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Junliang Fu, PhD, MD

Role: CONTACT

fjunliang@163.com

86-10-66933214

Fu-Sheng Wang, PhD, MD

Role: CONTACT

fswang302@163.com

86-10-66933328

Facility Contacts

Junliang Fu, PhD, MD

Role: primary

fjunliang@163.com

86-10-66933214

Fu-Sheng Wang, PhD, MD

Role: backup

fswang302@163.com

86-10-66933328

Other Identifiers

KY-2024-3-48-2

Identifier Type: -

Identifier Source: org_study_id