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Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody

ConditionHepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing 302 Hospital

About this trial

The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in patients with hepatocellular carcinoma resistant to PD-1 monoclonal antibody.

Hepatocellular Carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 75 (≤75), gender unlimited.

Hepatocellular Carcinoma diagnosed according to the 2018 edition of the EASL guidelines.

BCLC stage B or C.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • γδ T cells

    Biological/Vaccine

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

  • PD-1 monoclonal antibody

    Drug

    Humanized programmed death receptor (PD-1) monoclonal antibody that binds to PD- and prevents binding of PD-1 with programed death ligands 1 (PD-L1) and PD-L2. It can function to activate cytotoxic T lymphocytes and inhibit tumor growth.

  • targeted drugs

    Drug

    Multi-target kinase inhibitors can act on VEGFR-1,VEGFR-2,VEGFR-3,FGFR1,PDGFR,cKit,Ret and other targets.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: γδ T cells+ PD-1 monoclonal antibody+ targeted drugsExperimental treatment 3 interventions
Group B: PD-1 monoclonal antibody+ targeted drugsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
up to 60 weeks
2

Safety evaluation: Dose limited toxicity (DLTs)

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

Time frame
up to 60 weeks
3

Efficacy evaluation: Objective Response Rate(ORR)

Objective clinical response will be assessed by investigators up to 15months

Time frame
up to 15months
4

Efficacy evaluation: Duration of Response(DOR)

he duration of objective response in patients will be recorded until 15months after the start of 1st cycle of treatment

Time frame
up to 15months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing 302 Hospital

Lead sponsor

Chinese Academy of Medical Sciences

Collaborator

Beijing GD Initiative Cell Therapy Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: