CClinicalTrials.gg
Status unknownNCT04032392Updated Jul 25, 2019

Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells

A Phase 1 interventional study of autologous γδT cells in Hepatocellular Carcinoma, sponsored by Beijing 302 Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Beijing 302 Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, fresh biopsy and screening, apheresis, γδT cells preparation, treatment and follow-up. The study will evaluate the safety, tolerability and efficacy of autologous γδT cells in patients with advanced hepatitis B related hepatocellular carcinoma (HCC) which are refractory to current treatment.

Stage I comprising a safety cohort of patients to identify a safe dose, Stage II comprising an expanded patient group for response signal identification, Stage III to confirm efficacy and safety.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular carcinoma
  • Hepatitis B
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients should sign informed consent form voluntarily and comply with the requirements of this study.
  2. Gender unlimited, age 18 to 70 years old.
  3. Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
  4. 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.
  5. Liver function: Child-Pugh class A/B (5-9), Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  6. Expected survival ≥ 6 months.
  7. Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study.

Exclusion criteria

Exclusion Criteria:

  1. Combine other viral liver diseases or other liver disease patients.
  2. Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.
  3. Pregnant or lactating women; patients after organ transplantation; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
  4. 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.
  5. 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.
  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 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.
  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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Autologous γδT cells

    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

  • Biologicalautologous γδT cells

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 months

  2. 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.

    Time frame: 14 months

Secondary outcomes

  1. Objective Response Rate (ORR)

    The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the response evaluation criteria in solid tumors (RECIST) guideline.

    Time frame: 14 months

  2. Patients-based Quality of Life Evaluation

    According to the European Organization for Research and Treatment of Cancer (EORTC) quality of life of the core scale criteria QLQ-C30 to evaluate and compare patients life quality before and after treatment.

    Time frame: 14 months

07

Study locations

2 sites
  • Beijing 302 Hospital of China
    Beijing, Beijing 100039, China
    • Fu-Sheng Wang, MD · Contact · fswang302@163.com · 01066933328
    • Fu-Sheng Wang, MD · Principal investigator
  • Beijing 302 hospital
    Beijing, 100039, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04032392
Lead sponsor
Beijing 302 Hospital
Collaborators
Chinese Academy of Medical Sciences
Responsible party
Sponsor
First posted
Jul 25, 2019
Start date
Jul 23, 2019 (estimated)
Primary completion
Jul 30, 2021 (estimated)
Completion
Jul 30, 2022 (estimated)
Last update
Jul 25, 2019

Study contacts

Yuanyuan Li, Dr
Contact
lyy020818@sina.com
+86 01066933333
Fu-Sheng Wang, Dr
principal investigator · Beijing 302 Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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