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

NCT04518774 | Unknown Early Phase 1 DMC

• 1 other identifier: JDH-HCC-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatocellular Carcinoma

Keywords

allogeneic γδT cells; hepatocellular carcinoma; adoptive immunotherapy

Outcome Measures

Primary Outcomes (3)

• Safety evaluation: Incidence of Adverse events (AEs)

  Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

  up to 48 weeks

• Safety evaluation: Dose limited toxicity (DLTs)

  The incidence, characteristic and severity of DLTs will be recorded and assessed.

  up to 48 weeks

• Safety evaluation: Maximum-tolerated dose (MTD)

  MTD or clinical recommended dose will be recorded and evaluated.

  up to 48 weeks

Secondary Outcomes (3)

• Efficacy evaluation: Quality of life by ECOG score

  up to 48 weeks

• Efficacy evaluation: Tumor markers

  up to 48 weeks

• Efficacy evaluation: γδT cells in peripheral blood

  up to 48 weeks

Study Arms (1)

Allogeneic γδT cell immunotherapy

EXPERIMENTAL

Patients will receive 3 cycles of ex-vivo expanded allogeneic γδT cells treatments, at four-weeks' intervals, each cycle has 2 infusions. Ex-vivo expanded γδT cells are transfused to patients in a dosage escalated manner (Dose escalation, 1×107, 3×107, 9×107 per kg of body weight).

Biological: Ex-vivo expanded allogeneic γδT cells

Interventions

Ex-vivo expanded allogeneic γδT cells BIOLOGICAL

Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.

Allogeneic γδT cell immunotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Sign informed consent form.
• Age 18 years up to the age of 50 (≤50), gender unlimited.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Chinese Academy of Medical Sciences: collaborator
• Beijing GD Initiative Cell Therapy Technology Co., Ltd.: collaborator

Study Sites (2)

Beijing 302 Hospital of China

Beijing, Beijing Municipality, 100039, China

RECRUITING

Beijing 302 hospital

Beijing, 100039, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: August 15, 2020
• Primary Completion: June 15, 2021
• Study Completion: August 15, 2021
• Last Updated: August 19, 2020

Record last verified: 2020-07

Locations

CN (2)