Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells

NCT04032392 | Unknown Phase 1

• 1 other identifier: Beijing302-013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Hepatitis B

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.

  14 months

• Overall survival (OS)

  Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.

  14 months

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  14 months

• Patients-based Quality of Life Evaluation

  14 months

Study Arms (1)

Autologous γδT cells

EXPERIMENTAL

Subjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions. Dose escalation subjects will receive 6 infusions with dose of γδT cells escalation from 1×10e9 to 6×10e9. Constant dose subjects will have single infusion intravenously at a target dose of 1\~2×10e9 γδT cells.

Biological: autologous γδT cells

Interventions

autologous γδT cells BIOLOGICAL

Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.

Autologous γδT cells

Eligibility Criteria

• Age: 18 Years - 70 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 and comply with the requirements of this study.
• Gender unlimited, age 18 to 70 years old.
• Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
• According to the 2018 edition of the EASL guidelines for primary liver cancer, patients were diagnosed with advanced HBV-related hepatocellular carcinoma (BCLC stage B and C) by pathology and imaging; all patients required antiviral therapy with nucleoside analogues; other treatments (e.g. interventional therapy) at least 2 weeks prior to γδT cell infusion; 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 status 0-2.
• Expected survival ≥ 6 months.
• Male and female 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:

• Combine other viral liver diseases or other liver disease patients.
• Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.
• Pregnant or lactating women; patients after organ transplantation; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
• Dysfunction of major organs; patient white blood cell count \<1.0×10e9/L, platelet count \<60×10e9/L, hemoglobin \<86g/L, prothrombin time (INR) \>2.3, or prolonged clotting time \>6 seconds, serum albumin \<28g/L, total bilirubin \>51mmol/L, ALT/AST \>5 times the upper limit of normal, creatinine \>1.5 times the upper limit of normal.
• Combined with other serious organic diseases, mental illnesses, including any uncontrolled clinically significant systemic 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 six months prior to screening or during treatment; 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (2)

Beijing 302 Hospital of China

Beijing, Beijing Municipality, 100039, China

Location

Beijing 302 hospital

Beijing, 100039, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis B

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; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• Fu-Sheng Wang, Dr

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanyuan Li, Dr

CONTACT

+86 01066933333; lyy020818@sina.com

Study Design

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

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 25, 2019
• Study Start: July 23, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2022
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)