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Trial Title:
Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma
NCT ID:
NCT06364787
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
γδ T cells
Description:
Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion
and activation. The ex-vivo expanded γδ T cells from donors will be adoptively
transfused.
Arm group label:
γδ T cells+ PD-1 monoclonal antibody+ targeted drugs
Intervention type:
Drug
Intervention name:
Targeted drugs
Description:
Multi-target kinase inhibitors can act on VEGFR-1,VEGFR-2,VEGFR-3,FGFR1,PDGFR,cKit,Ret
and other targets.
Arm group label:
PD-1 monoclonal antibody+ targeted drugs
Arm group label:
γδ T cells+ PD-1 monoclonal antibody+ targeted drugs
Intervention type:
Drug
Intervention name:
PD-1 monoclonal antibody
Description:
Humanized programmed death receptor (PD-1) monoclonal antibody that binds to PD- and
prevents binding of PD-1 with programed death ligands 1 (PD-L1) and PD-L2. It can
function to activate cytotoxic T lymphocytes and inhibit tumor growth.
Arm group label:
PD-1 monoclonal antibody+ targeted drugs
Arm group label:
γδ T cells+ PD-1 monoclonal antibody+ targeted drugs
Summary:
The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells
combined with targeted therapy and PD-1 monoclonal antibody in first-line treatment of
patients with hepatocellular carcinoma.
Detailed description:
This is a double-arm, single-center, randomized, open label phase I clinical trial to
evaluate the efficacy and safety of the combination of ex-vivo expanded allogeneic γδ T
cells plus targeted therapy and PD-1 monoclonal antibody in patients with BCLC stage B or
C hepatocellular carcinoma (HCC). A typical 3+3 dose-escalation design will be used to
determine the optimal dose level of γδ T cells based on the incidence of dose-limiting
toxicity (DLT). The initial infusion dose level will start from 1×10^8/kg to 4×10^8/kg in
every 3 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients should sign informed consent form voluntarily before the trail and comply
with the requirements of this study.
2. Age 18 years up to the age of 75 (≤75), gender unlimited.
3. Hepatocellular Carcinoma diagnosed according to the 2018 edition of the EASL
guidelines.
4. BCLC stage B or C.
5. Liver function: Child-Pugh class A/B (5-9).
6. Eastern Cooperative Oncology Group (ECOG) Performance score≤1.
7. No previous antitumor therapy.
8. Life expectancy ≥ 6 months.
9. Patients combined with HBV infection require antiviral treatment with nucleoside
analogues; patients combined with HCV infection require direct-acting antiviral
agent (DAA) treatment.
10. Adequate organ and marrow function (within 4 weeks prior to study treatment
initiation).
11. Male and female patients of reproductive potential must agree to use birth control
during the study and for at least 30 days post study.
12. Capable of understanding and complying with the study protocol requirements (
including follow-up visit and examinations).
13. Be willing to signed a written informed consent document before enrollment.
Exclusion Criteria:
1. Patients combined with HAV, HEV, HIV or other infectious diseases.
2. Acute infections, gastrointestinal bleeding, etc. occurred within 30 days before
screening.
3. Women who are pregnant (urine/blood pregnancy test positive) or lactating; patients
with severe autoimmune diseases; patients with uncontrolled infectious diseases.
4. Major organs dysfunction.
5. Combined with other severe organic diseases or mental illnesses, including any
uncontrolled clinically significant systematic diseases such as urinary,
circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune
diseases.
6. Allergic constitution, history of allergies to blood products, known to be allergic
to test substances.
7. Immunosuppressive or systemic cytotoxic drugs may require within 6 months prior to
screening or during the study; 6 months prior to screening accepted other cell
therapies including NK, CIK, DC, CTL and stem cell therapy etc.
8. Patients currently participating in other clinical trials who may violate this
treatment plan and observations.
9. Those who are unable or unwilling to provide informed consent or who are unable to
comply with the research requirements.
10. Any situation that investigators believe the risk of the subjects is increased or
results of the trial are disturbed: patients with any serious acute or chronic
physical or mental illness, or laboratory abnormalities.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 26, 2024
Completion date:
September 26, 2026
Lead sponsor:
Agency:
Beijing 302 Hospital
Agency class:
Other
Collaborator:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Beijing GD Initiative Cell Therapy Technology Co., Ltd.
Agency class:
Industry
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/NCT06364787
