Allogeneic "Gammadelta T Cells (γδ T Cells)" Cell Immunotherapy in Phase 1 Hepatocellular Carcinoma Clinical Trial

Patient Inclusion Criteria:

1. Patients should sign informed consent form voluntarily before the trail and complywith the requirements of this study.

2. Age 18 years up to the age of 65 (≤65), gender unlimited.

3. Hepatocellular Carcinoma diagnosed according to the 2018 edition of the EASLguidelines. Patients should accept liver biopsy voluntarily and histopathologicallydiagnosed with HCC.

4. Interventional therapy (e.g. TACE), RFA or radiation therapy should be at least 2weeks prior to γδT cell transfusion; surgical treatment should be at least 1 monthprior to γδT cell transfusion. Patients can take the first- or second-line targeteddrugs recommended by the guidelines, such as lenvatinib or sorafenib.

5. Liver function: Child-Pugh class A/B (5-9)

6. Eastern Cooperative Oncology Group (ECOG) Performance score≤2.

7. Life expectancy of at least 1 year.

8. Patients combined with HBV infection require antiviral treatment with nucleosideanalogues; patients combined with HCV infection require direct-acting antiviral agent (DAA) treatment.

9. Male and female patients of reproductive potential must agree to use birth controlduring the study and for at least 30 days post study.

Patient Exclusion Criteria:

1. Patients combined with HAV, HEV, HIV or other infectious diseases.

2. Acute infections, gastrointestinal bleeding, etc. occurred within 30 days beforescreening.

3. Women who are pregnant (urine/blood pregnancy test positive) or lactating; patientswith severe autoimmune diseases; patients with uncontrolled infectious diseases.

4. Major organs dysfunction:

• Peripheral blood: WBC<1.0×109/L, PLT <60×109/L, Hb <86g/L;

• Coagulation: INR>2.3, PT>18s;

• Liver function: ALB<28g/L, TBIL>51mmol/L, ALT/AST>5 times the upper limit ofnormal, CREA>1.5 times the upper limit of normal.

5. Combined with other severe organic diseases or mental illnesses, including anyuncontrolled 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 totest substances.

7. Immunosuppressive or systemic cytotoxic drugs may require within 6 months prior toscreening or during the study; 6 months prior to screening accepted other celltherapies including NK, CIK, DC, CTL and stem cell therapy etc.; immunotherapy such asPD-1 and PD-L1 antibodies.

8. Patients currently participating in other clinical trials who may violate thistreatment plan and observations.

9. Those who are unable or unwilling to provide informed consent or who are unable tocomply with the research requirements.

10. Any situation that investigators believe the risk of the subjects is increased orresults of the trial are disturbed: patients with any serious acute or chronicphysical or mental illness, or laboratory abnormalities. Donor Inclusion Criteria:

11. Sign informed consent form.

12. Age 18 years up to the age of 50 (≤50), gender unlimited.

13. Relative to patients (unrestricted to blood relationship).

14. Apheresis available.

15. PLT≥100×109/L with normal APTT or PT. Donor Exclusion Criteria:

16. History of any severe clinical diseases or other severe organic diseases, includingany history of clinically significant systematic diseases such as cardiovascular,urinary, circulatory, respiratory, neurological, psychiatric, digestive and endocrinediseases. History of high blood pressure or systolic pressure>140 mmHg, diastolicpressure>90 mmHg in screening stage. Any situation that investigators believe isclinically significant or with other severe diseases unsuitable of apheresis.

17. Arterial thrombosis or venous thrombosis history 12 months prior to the trial orhemorrhagic tendency or history 2 months prior to the trial; oral administration ofanticoagulation drugs (e. g. aspirin and warfarin).

18. Active or history of autoimmune diseases including but not restricted to SLE,psoriasis, RA, IBD and HT. Apart from hypothyrosis which can be controlled by hormonereplacement therapy, skin diseases without systemic therapy and celiac disease whichis fully controlled.

19. HIV-Ab, TP-Ab, HCV-Ab, HBsAg, HBeAg, HBeAb or HBcAb positive.

20. Any symptom, sign or laboratory examination abnormality suggesting acute or subacuteinfection (e.g. fever, cough, urinary irritation, skin infectious wound).

21. Female who are pregnant or cannot stop lactating.

22. Those who cannot communicate with medical staff due to mental illness or languagedisabilities.

23. Other unsuitable conditions that investigators believe unsuitable for the donation.