Hepatocellular CarcinomaPhase 1NCT06364787
Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma
A Phase 1 study testing γδ T cells, Targeted drugs and PD-1 monoclonal antibody in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital.
Trial summary
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 first-line treatment of patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- γδ T cells, Targeted drugs and PD-1 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2024to 26 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Liver function: Child-Pugh class A/B (5-9).
- Eastern Cooperative Oncology Group (ECOG) Performance score≤1.
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- No previous antitumor therapy.
- Life expectancy ≥ 6 months.
- Patients combined with HBV infection require antiviral treatment with nucleoside analogues; patients combined with HCV infection require direct-acting antiviral agent (DAA) treatment.
- Adequate organ and marrow function (within 4 weeks prior to study treatment initiation).
- Male and female patients of reproductive potential must agree to use birth control during the study and for at least 30 days post study.
- Capable of understanding and complying with the study protocol requirements ( including follow-up visit and examinations).
- Be willing to signed a written informed consent document before enrollment.
Who cannot join
- 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.
- 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.
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- 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.
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Safety and Efficacy Assessment of Allogeneic γδ T Cells Combined With Targeted Therapy and Immunotherapy in Hepatocellular Carcinoma Patients
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 first-line treatment of patients with hepatocellular carcinoma.
Read the detailed description
This is a double-arm, single-center, randomized, open label phase I clinical trial to evaluate the efficacy and safety of the combination of ex-vivo expanded allogeneic γδ T cells plus targeted therapy and PD-1 monoclonal antibody in patients with BCLC stage B or C hepatocellular carcinoma (HCC). A typical 3+3 dose-escalation design will be used to determine the optimal dose level of γδ T cells based on the incidence of dose-limiting toxicity (DLT). The initial infusion dose level will start from 1×10^8/kg to 4×10^8/kg in every 3 weeks.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- γδ T cells, Targeted drugs, PD-1 monoclonal antibody
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
γδ T cellsBiological
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.
Targeted drugsDrug
Multi-target kinase inhibitors can act on VEGFR-1,VEGFR-2,VEGFR-3,FGFR1,PDGFR,cKit,Ret and other targets.
PD-1 monoclonal antibodyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| γδ T cells+ PD-1 monoclonal antibody+ targeted drugs | Experimental | Patients will receive 4 cycles of ex-vivo expanded allogeneic γδ T cells treatments, at three-weeks' intervals. Ex-vivo expanded γδ T cells are transfused to patients in a typical 3+3 dose-escalation design (Dose escalation, 1×10^8/kg, 2×10^8/kg,4×10^8/kg). Receives: Biological: γδ T cells; Drug: Targeted drugs; Drug: PD-1 monoclonal antibody |
| PD-1 monoclonal antibody+ targeted drugs | Active comparator | PD-1 monoclonal antibody+ targeted drugs Receives: Drug: Targeted drugs; Drug: PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 60 weeks
Safety evaluation: Dose limited toxicity (DLTs)
The incidence, characteristic and severity of DLTs will be recorded and assessed.
Measured: up to 60 weeks
Safety evaluation: Maximum-tolerated dose (MTD)
MTD or clinical recommended dose will be recorded and evaluated.
Measured: up to 60 weeks
Efficacy evaluation: Objective Response Rate(ORR)
Objective clinical response will be assessed by investigators
Measured: up to 15months
Efficacy evaluation: Duration of Response(DOR)
The duration of objective response in patients will be recorded until 15months after the start of 1st cycle of treatment
Measured: up to 15months
Efficacy evaluation: Progress Free Survival(PFS)
Observation for progression-free survival (PFS) will be recorded until 15 months after the start of 1st cycle of treatment
Measured: up to 15months
Efficacy evaluation: Overall Survival (OS)
Observation for overall survival l (OS) will be recorded until 15 months after the start of 1st cycle of treatment.
Measured: up to 15months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start26 Apr 2024 (estimated)
- Primary completion26 Apr 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Beijing GD Initiative Cell Therapy Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364787
- Sponsor's protocol ID
- GDT-001-07-01
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Assessment of Allogeneic γδ T Cells Combined With Targeted Therapy and Immunotherapy in Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT06364787
- Acronym / sponsor ID
- GDT-001-07-01
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Beijing GD Initiative Cell Therapy Technology Co., Ltd.
- Study start
- 26 Apr 2024 (estimated)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 first-line treatment of patients with hepatocellular carcinoma.
Detailed description
This is a double-arm, single-center, randomized, open label phase I clinical trial to evaluate the efficacy and safety of the combination of ex-vivo expanded allogeneic γδ T cells plus targeted therapy and PD-1 monoclonal antibody in patients with BCLC stage B or C hepatocellular carcinoma (HCC). A typical 3+3 dose-escalation design will be used to determine the optimal dose level of γδ T cells based on the incidence of dose-limiting toxicity (DLT). The initial infusion dose level will start from 1×10^8/kg to 4×10^8/kg in every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| γδ T cells+ PD-1 monoclonal antibody+ targeted drugs | Experimental | Biological: γδ T cells, Drug: Targeted drugs, Drug: PD-1 monoclonal antibodyPatients will receive 4 cycles of ex-vivo expanded allogeneic γδ T cells treatments, at three-weeks' intervals. Ex-vivo expanded γδ T cells are transfused to patients in a typical 3+3 dose-escalation design (Dose escalation, 1×10^8/kg, 2×10^8/kg,4×10^8/kg). |
| PD-1 monoclonal antibody+ targeted drugs | Active comparator | Drug: Targeted drugs, Drug: PD-1 monoclonal antibodyPD-1 monoclonal antibody+ targeted drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Liver function: Child-Pugh class A/B (5-9).
Key exclusion criteria (10 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| γδ T cellsCells 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. | Biological | γδ T cells+ PD-1 monoclonal antibody+ targeted drugs |
| Targeted drugsMulti-target kinase inhibitors can act on VEGFR-1,VEGFR-2,VEGFR-3,FGFR1,PDGFR,cKit,Ret and other targets. | Drug | PD-1 monoclonal antibody+ targeted drugs, γδ T cells+ PD-1 monoclonal antibody+ targeted drugs |
| PD-1 monoclonal antibodyHumanized 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. | Drug | PD-1 monoclonal antibody+ targeted drugs, γδ T cells+ PD-1 monoclonal antibody+ targeted drugs |
Primary outcome
Safety evaluation: Incidence of Adverse events (AEs)
Time frame: up to 60 weeks
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).
Safety evaluation: Dose limited toxicity (DLTs)
Time frame: up to 60 weeks
The incidence, characteristic and severity of DLTs will be recorded and assessed.
Safety evaluation: Maximum-tolerated dose (MTD)
Time frame: up to 60 weeks
MTD or clinical recommended dose will be recorded and evaluated.
Efficacy evaluation: Objective Response Rate(ORR)
Time frame: up to 15months
Objective clinical response will be assessed by investigators
Efficacy evaluation: Duration of Response(DOR)
Time frame: up to 15months
The duration of objective response in patients will be recorded until 15months after the start of 1st cycle of treatment
Efficacy evaluation: Progress Free Survival(PFS)
Time frame: up to 15months
Observation for progression-free survival (PFS) will be recorded until 15 months after the start of 1st cycle of treatment
Efficacy evaluation: Overall Survival (OS)
Time frame: up to 15months
Observation for overall survival l (OS) will be recorded until 15 months after the start of 1st cycle of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing γδ T cells, Targeted drugs and PD-1 monoclonal antibody in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Fan-Ping, Ph.D (66933126-6019, drmengfanping@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation: Incidence of Adverse events (AEs) (time frame: up to 60 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.