Status:
UNKNOWN
Allogeneic "Gammadelta T Cells (γδ T Cells)" Cell Immunotherapy in Phase 1 Hepatocellular Carcinoma Clinical Trial
Lead Sponsor:
Beijing 302 Hospital
Collaborating Sponsors:
Chinese Academy of Medical Sciences
Beijing GD Initiative Cell Therapy Technology Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This study aims to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells obtained from a blood-related donor of hepatocellular carcinoma patients.
Detailed Description
This study is a single-center, non-randomized, open label, no control, prospective clinical trial to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells from of a b...
Eligibility Criteria
Inclusion
- Patient
- Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
- Age 18 years up to the age of 65 (≤65), gender unlimited.
- Hepatocellular Carcinoma diagnosed according to the 2018 edition of the EASL guidelines. Patients should accept liver biopsy voluntarily and histopathologically diagnosed with HCC.
- Interventional therapy (e.g. TACE), RFA or radiation therapy should be at least 2 weeks prior to γδT cell transfusion; surgical treatment should be at least 1 month prior to γδT cell transfusion. Patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
- Liver function: Child-Pugh class A/B (5-9)
- Eastern Cooperative Oncology Group (ECOG) Performance score≤2.
- Life expectancy of at least 1 year.
- Patients combined with HBV infection require antiviral treatment with nucleoside analogues; patients combined with HCV infection require direct-acting antiviral agent (DAA) treatment.
- Male and female patients of reproductive potential must agree to use birth control during the study and for at least 30 days post study.
- Patient
Exclusion
- Patients combined with HAV, HEV, HIV or other infectious diseases.
- Acute infections, gastrointestinal bleeding, etc. occurred within 30 days before screening.
- Women who are pregnant (urine/blood pregnancy test positive) or lactating; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
- 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 of normal, CREA\>1.5 times the upper limit of normal.
- 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.
- Allergic constitution, history of allergies to blood products, known to be allergic to test substances.
- 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.; immunotherapy such as PD-1 and PD-L1 antibodies.
- Patients currently participating in other clinical trials who may violate this treatment plan and observations.
- Those who are unable or unwilling to provide informed consent or who are unable to comply with the research requirements.
- 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.
- Donor Inclusion Criteria:
- Sign informed consent form.
- Age 18 years up to the age of 50 (≤50), gender unlimited.
- Relative to patients (unrestricted to blood relationship).
- Apheresis available.
- PLT≥100×109/L with normal APTT or PT.
- Donor
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04518774
Start Date
August 15 2020
End Date
August 15 2021
Last Update
August 19 2020
Active Locations (2)
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1
Beijing 302 Hospital of China
Beijing, Beijing Municipality, China, 100039
2
Beijing 302 hospital
Beijing, China, 100039