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

NCT ID: NCT06463522

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Conditions: Keywords:
Hepatocellular Carcinoma
Tumor-infiltrating Lymphocytes

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Autologous Tumor-infiltrating Lymphocytes Therapy

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Autologous Tumor-infiltrating Lymphocytes
Description: Autologous Tumor-infiltrating Lymphocytes, 2.0*10^7/Kg, single intravenous infusion.
Arm group label: Tumor-infiltrating Lymphocytes Therapy

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: the Fifth Medical Center of PLA

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Junliang Fu, PhD, MD

Phone: 86-10-66933214
Email: fjunliang@163.com

Contact backup:
Last name: Fu-Sheng Wang, PhD, MD

Phone: 86-10-66933328
Email: fswang302@163.com

Start date: July 1, 2024

Completion date: July 1, 2026

Lead sponsor:
Agency: Beijing 302 Hospital
Agency class: Other

Source: Beijing 302 Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06463522

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