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

B

Beijing 302 Hospital

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Autologous Tumor-infiltrating Lymphocytes

Study type

Interventional

Funder types

Other

Identifiers

NCT06463522
KY-2024-3-48-2

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Tumor-infiltrating Lymphocytes Therapy
Experimental group
Description:
Autologous Tumor-infiltrating Lymphocytes Therapy, 2.0\*10\^7/Kg, single intravenous infusion.
Treatment:
Procedure: Autologous Tumor-infiltrating Lymphocytes

Trial contacts and locations

1

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Central trial contact

Junliang Fu, PhD, MD; Fu-Sheng Wang, PhD, MD

Data sourced from clinicaltrials.gov

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