Clinical trial NCT06463522: Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
Official title: Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Tumor-infiltrating Lymphocytes
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Autologous Tumor-infiltrating Lymphocytes Therapy
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: day0, day3, week1, week2, week4, week12, week24
Secondary outcomes:
measure: Concentration of Total Bilirubin (TBIL, mg/dL)
timeFrame: day0, day3, week1, week2, week4, week12, week24
measure: Child-Turcotte-Pugh(CTP) score
timeFrame: day0, day3, week1, week2, week4, week12, week24
measure: Quality of life of patients
timeFrame: day0, day3, week1, week2, week4, week12, week24
Other outcomes:
Locations:
city: Beijing
country: China
facility: the Fifth Medical Center of PLA
Study officials:
affiliation: the Fifth Medical Center of PLA
name: Junliang Fu, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: