Advanced Hepatocellular CarcinomaEarly Phase 1NCT05070156

B010-A Injection for Treating Patients With GPC3 Positive Advanced Hepatocellular Carcinoma

A Early Phase 1 study testing Biological/Vaccine: Low-dose group, Biological/Vaccine: Mid-dose group and Biological/Vaccine: High-dose group in people with Advanced Hepatocellular Carcinoma, run by Tongji University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is an Open-label, Single Arm study to observe the safety and tolerability of B010-A in the treatment of advanced hepatocellular carcinoma. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Hepatocellular Carcinoma
What is being tested?: Biological/Vaccine: Low-dose group, Biological/Vaccine: Mid-dose group and Biological/Vaccine: High-dose group
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteChina
Study dates: 29 Oct 2021to 30 Sep 2024
Phase: Early 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

All subjects must meet all of the following criteria to be eligible for enrollment in this study:
Aged 18-75 years, male or female;
Subjects with histopathologically or cytologically confirmed advanced hepatocellular carcinoma (HCC) who are ineligible for surgery or local therapy, have progressed or being intolerant to prior standard systemic therapies (systemic therapies include but are not limited to systemic chemotherapy and molecular targeted therapy), or those who have no effective treatment options at the time of enrollment as judged by the investigator;
Subjects with at least one stable and evaluable intrahepatic or extrahepatic target lesion (longest diameter of non-nodal lesions ≥ 10 mm, or short axis of lymph node lesions ≥ 15 mm) at enrollment as per RECIST V1.1 criteria;
Subjects with GPC3 positive (> grade 2) tumor tissue samples (> 25% tumor cells positive staining) as tested by immunohistochemistry (IHC);
Subjects with Barcelona Clinic Liver Cancer Stage C (BCLC-C) hepatocellular carcinoma, or subjects with BCLC Stage B hepatocellular carcinoma who are not amenable to local therapy or have progressed after local therapy;

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Subjects with expected survival > 12 weeks;
Subjects with liver cirrhosis of Child-Pugh grade A (5-6 points);
Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Subjects with inactive hepatitis B (if HBsAg or HBcAb is positive, then HBV-DNA must be < 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral therapies as per the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition));
The largest diameter of intrahepatic tumors is < 10 cm, and the number of multiple tumors is < 10 (if pulmonary metastatic lesions are present, the number of metastatic lesions is < 6);
Subjects with a venous access for mononuclear cell collection;
Subjects with adequate bone marrow function that allows for lympho-depleting pre-conditioning and without contraindications for the pre-conditioning as assessed by the investigator;
Subjects with liver, kidney, respiratory, cardiovascular functions, and corresponding hematological levels as defined below:
Alanine aminotransferase (ALT) ≤ 5.0 × ULN, aspartate aminotransferase (AST) ≤ 5.0 × ULN, and total bilirubin ≤ 2.5 × ULN at screening;
Requirements for blood coagulation at screening: prothrombin time (PT) prolongation ≤ 4 s, fibrinogen ≥ 1 g/L, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
Serum creatinine ≤ 1.5 × ULN or endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault formula) at screening;
Pulmonary function at screening: finger oxygen saturation ≥ 95% at screening and prior to apheresis;
Cardiac function at screening: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography within 1 month;
Subjects with white blood cell count ≥ 3.0×109/L and lymphocyte count ≥ 0.5×109/L at screening (except for those receiving bridging chemotherapy), platelet count ≥ 75×109/L, hemoglobin ≥ 90 g/L, and neutrophil count ≥ 1.5×109/L (this criterion should also be met within 24 hours prior to apheresis).
Female subjects of childbearing potential (all women physiologically capable of becoming pregnant) must have a negative serum pregnancy test both at screening and within 14 days prior to the first dose and are willing to use reliable contraception methods during the study (within 24 months after the first dose of cell infusion). For male subjects whose partners are women of childbearing potential, the subjects should have been surgically sterilized or agree to use reliable contraception methods during the study as well as for additional 1 year after receiving the last study treatment;
Subjects with ability to understand and sign the Informed Consent Form.

Who cannot join

Subjects who meet any of the following criteria cannot participate in this study:
Having other uncured malignancies (except cervical carcinoma in situ and basal cell carcinoma of skin) within the past 5 years or at present, or hepatocellular carcinoma with brain metastases;
With a history of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Grade III or IV heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases, or poorly controlled high blood pressure (systolic blood pressure > 150 mm Hg, or diastolic blood pressure > 90 mm Hg), or hypotension that requires treatment with vasopressors;
With metastases to the central nervous system (CNS) and clinically significant CNS disorders; with prior or clinically significant CNS diseases at screening, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, brain organic syndrome or psychiatric disorder;
With prior hepatic encephalopathy or at present;
With a history of serious lung diseases, including pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease and clinically significant abnormal findings in pulmonary function tests;

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With an active infection (uncontrolled active infections caused by bacteria, viruses, or fungus requiring systemic therapy) at screening, or has an unexplained fever of ≥ 38.0 °C during screening or prior to the first dose;
With known active autoimmune diseases requiring immunosuppressive therapy, including biologics;
With a history of organ transplantation or awaiting organ transplantation (including liver transplantation);
With ≥ 50% of liver replaced by tumor, or with the main portal vein tumor thrombus, or the mesenteric vein/inferior vena cava has been invaded by tumor thrombus;
With a co-infection of HBV and HCV viruses or infections caused by more than two viruses;
Positive HCV-RNA, HIV antibody, or syphilis serology, or any other uncontrollable active infections;
Requiring long-term antiplatelet therapy (aspirin > 300 mg/day; clopidogrel > 75 mg/day);
Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
With moderate or higher amount of pleural effusion/ascites with clinical symptoms, or have undergone drainage of pleural effusion/ascites within the past month (except for those with only small amounts of pleural effusion/ascites revealed by imaging examinations but without symptoms);
With active bleeding or coagulation test abnormalities, bleeding tendency or undergoing thrombolytic, anticoagulant, or antiplatelet therapy (except those requiring heparin due to PICC or deep vein catheterization), or massive bleeding/blood loss (greater than 450 mL) within 28 days;
With a history of gastrointestinal bleeding within 3 months or definite tendency of gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood positive);
Having received any of the following treatments:
Have received supportive care such as blood transfusion, platelet transfusion, cell growth factors (except recombinant erythropoietin) within 2 weeks prior to apheresis:
Have received anti-PD-1/PD-L1 monoclonal antibody treatment within 4 weeks prior to apheresis;
Have used any study drug within 4 weeks prior to apheresis, except those who have failed to respond to the study treatment or have experienced disease progression during study treatment and at least 3 half-lives have passed prior to peripheral blood mononuclear cell collection);
Have undergone any surgical treatment, interventional therapy, chemoradiotherapy, ablation, targeted therapy, treatments with invasive investigational medical devices, or are receiving immunomodulatory therapy for the disease under study within 2 weeks prior to apheresis;
With prior use of prednisone at doses ≥ 15 mg /day (or equivalent glucocorticoids) systemically within 2 weeks prior to apheresis, or may require long-term glucocorticoid therapy during study treatment as judged by the investigator (except those who have recently or are currently using inhaled or topical glucocorticoids);
Have received any Chinese herbal medicine or Chinese patent medicine to control liver cancer within 2 weeks prior to apheresis.
With previous allergic reactions to immunotherapy, have received related drugs (such as tocilizumab, cyclophosphamide), or excipients or matrix components contained in B010-A for Injection (e.g., albumin, dimethyl sulfoxide, etc.);
Toxicities caused by prior treatments have not recovered to CTCAE Grade ≤ 1, except for alopecia and other events judged as tolerable by the investigator;
Unable or unwilling to comply with protocol requirements as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072

Other trials in China

About this study

Official title: A Phase 1 Open-label, Single Arm Study Targeting Glypican-3 (GPC3) Chimeric Antigen Receptor Modified T Cells (CAR-T) for Treatment of Advanced Hepatocellular Carcinoma

This is an Open-label, Single Arm study to observe the safety and tolerability of B010-A in the treatment of advanced hepatocellular carcinoma.

Read the detailed description

All subjects participating in this study will receive peripheral blood mononuclear cell collection to produce B010-A injection products after enrollment. Subjects may receive bridging anti-cancer therapy while waiting for the production of B010-A injection. All subjects need to undergo baseline assessment before receiving cell infusion. For all subjects, the baseline assessment includes weight, body surface area, vital signs, physical examination, ECOG score, laboratory examination, coagulation function, etiological examination, 12-lead ECG, echocardiogram, cytokine testing, Tumor marker detection and ICE score, etc. Each subject will receive lymphodepletion prior to B010-A infusion, and dose-limiting toxicity (DLT) assessment will be performed on D28 after the first infusion.

Conditions: Advanced Hepatocellular Carcinoma
Being tested: Biological/Vaccine: Low-dose group, Biological/Vaccine: Mid-dose group, Biological/Vaccine: High-dose group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biological/Vaccine: Low-dose groupBiological
1.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
Biological/Vaccine: Mid-dose groupBiological
2.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
Biological/Vaccine: High-dose groupBiological
3.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.

Study groups in NCT05070156
Study group	Role	What they receive
Experimental: B010-A injection for patient with GPC3 Positive Hepatocellular Carcinoma	Experimental	Not described Receives: Biological: Biological/Vaccine: Low-dose group; Biological: Biological/Vaccine: Mid-dose group; Biological: Biological/Vaccine: High-dose group

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability] after B010-A injection.
Measured: Up to 24 months post B010-A injection.

Secondary outcomes (11)

Evaluate the cellular kinetics of subjects after B010-A injection.
Copy number of transgenes of GPC3-CAR-T (qPCR).
Measured: Up to 24 months post B010-A injection.
Evaluate the cellular kinetics of subjects after B010-A injection.
Copy number of CAR-T cell transgene level detection (flow cytometry).
Measured: Up to 24 months post B010-A injection.
Evaluate the pharmacodynamics of subjects after B010-A injection.
Measurement of cytokine.
Measured: Up to 24 months post B010-A injection.
Evaluate the pharmacodynamics of subjects after B010-A injection.
Measurement of C-reactive protein (CRP).
Measured: Up to 24 months post B010-A injection.
Evaluate the preliminary efficacy of B010-A after injection.
Measurement of free GPC3 protein in peripheral blood, and lymphocyte subpopulation.
Measured: Up to 24 months post B010-A injection.
Progression-free survival (PFS)
Determination of the progression-free survival of all subjects
Measured: Up to 24 months post B010-A injection.
Overall survival (OS)
Determination of the overall survival of all subjects
Measured: Up to 24 months post B010-A injection.
Objective remission rate (ORR)
Determination of the objective remission rate of all subjects
Measured: Up to 24 months post B010-A injection.
Disease control rate (DCR)
Determination of the disease control rate of all subjects
Measured: Up to 24 months post B010-A injection.
Duration of remission (DOR)
Determination of the duration of remission of all subjects
Measured: Up to 24 months post B010-A injection.
Disease control Time (DDC)
Determination of the disease control time of all subjects
Measured: Up to 24 months post B010-A injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202130 Sep 2024

First posted7 Oct 2021
Study start29 Oct 2021
Primary completion31 Aug 2024 (estimated)
Study completion30 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070156
Sponsor's protocol ID: B010-A-001
Status last verified: Dec 2023
First submitted: 10 Sep 2021
Last updated: 15 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))

All Advanced Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-label, Single Arm Study Targeting Glypican-3 (GPC3) Chimeric Antigen Receptor Modified T Cells (CAR-T) for Treatment of Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT05070156
Acronym / sponsor ID: B010-A-001
Conditions: Advanced Hepatocellular Carcinoma
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 3 participants (actual)
Lead sponsor: Tongji UniversityUniversity, hospital or other
Collaborators: Shanghai Pharmaceuticals Holding Co., Ltd
Study start: 29 Oct 2021 (actual)
Primary completion: 31 Aug 2024 (estimated)
Study completion: 30 Sep 2024 (estimated)
First posted: 7 Oct 2021 (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.

This is an Open-label, Single Arm study to observe the safety and tolerability of B010-A in the treatment of advanced hepatocellular carcinoma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental: B010-A injection for patient with GPC3 Positive Hepatocellular Carcinoma	Experimental	Biological: Biological/Vaccine: Low-dose group, Biological: Biological/Vaccine: Mid-dose group, Biological: Biological/Vaccine: High-dose group

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

All subjects must meet all of the following criteria to be eligible for enrollment in this study:

Key exclusion criteria (27 listed)

Subjects who meet any of the following criteria cannot participate in this study:

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
Biological/Vaccine: Low-dose group1.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.	Biological	Experimental: B010-A injection for patient with GPC3 Positive Hepatocellular Carcinoma
Biological/Vaccine: Mid-dose group2.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.	Biological	Experimental: B010-A injection for patient with GPC3 Positive Hepatocellular Carcinoma
Biological/Vaccine: High-dose group3.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.	Biological	Experimental: B010-A injection for patient with GPC3 Positive Hepatocellular Carcinoma

Primary outcome

Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability] after B010-A injection.
Time frame: Up to 24 months post B010-A injection.

11 secondary outcomes

Evaluate the cellular kinetics of subjects after B010-A injection.
Time frame: Up to 24 months post B010-A injection.
Evaluate the cellular kinetics of subjects after B010-A injection.
Time frame: Up to 24 months post B010-A injection.
Evaluate the pharmacodynamics of subjects after B010-A injection.
Time frame: Up to 24 months post B010-A injection.
Evaluate the pharmacodynamics of subjects after B010-A injection.
Time frame: Up to 24 months post B010-A injection.
Evaluate the preliminary efficacy of B010-A after injection.
Time frame: Up to 24 months post B010-A injection.
Progression-free survival (PFS)
Time frame: Up to 24 months post B010-A injection.
Overall survival (OS)
Time frame: Up to 24 months post B010-A injection.
Objective remission rate (ORR)
Time frame: Up to 24 months post B010-A injection.
Disease control rate (DCR)
Time frame: Up to 24 months post B010-A injection.
Duration of remission (DOR)
Time frame: Up to 24 months post B010-A injection.
Disease control Time (DDC)
Time frame: Up to 24 months post B010-A injection.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.

Related trials for Advanced Hepatocellular Carcinoma

Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))

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.

Qing Xu principal investigator

Shanghai 10th People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 22 inclusion and 27 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability] after B010-A injection. (time frame: Up to 24 months post B010-A injection.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070156.

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 Dec 2023.