Using patients' own immune cells to treat liver cancer

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

This study tests whether using patients' own modified immune cells can help people with advanced liver cancer feel better and fight the disease.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing 302 Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06463522 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes therapy in patients diagnosed with hepatocellular carcinoma (HCC). It is an open-label Phase 1 and Phase 2 trial that aims to determine how well this innovative treatment works for patients with advanced liver cancer. Participants will receive their own immune cells, which have been modified to target and attack cancer cells, in hopes of improving their condition. The study will monitor participants for safety and treatment outcomes over time.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a diagnosis of hepatocellular carcinoma at BCLC stage B or C and a life expectancy of more than three months.

Not a fit: Patients with severe liver dysfunction or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new, effective treatment option for patients with hepatocellular carcinoma.

How similar studies have performed: Other studies using tumor-infiltrating lymphocytes have shown promise in treating various cancers, suggesting potential success for this approach in 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.

Where this trial is running

Beijing

• the Fifth Medical Center of PLA — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Junliang Fu, PhD, MD — the Fifth Medical Center of PLA
• Study coordinator: Junliang Fu, PhD, MD

Conditions Hepatocellular Carcinoma; Tumor-infiltrating Lymphocytes