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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