Hepatocellular CarcinomaEarly Phase 1NCT06645314
Study on the Safety and Efficacy of BST06 Injection in the Treatment of Advanced Hepatocellular Carcinoma
A Early Phase 1 study testing Group A and Group B in people with Hepatocellular Carcinoma, run by BioSyngen Pte Ltd.
Trial summary
The study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Group A and Group B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 31 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: The age range is 18-70 years old (including the critical value);
- 2: HCC patients diagnosed by histopathological or cytological examination, or those who meet the criteria of the American Association for the Study of the Liver (AASLD) or are clinically diagnosed with hepatocellular carcinoma according to the "2022 Guidelines for the Diagnosis and Treatment of Primary Liver Cancer";
- 3: Tumor tissue pathology immunohistochemistry GPC3 positive;
- 4: Patients who have undergone at least first-line systemic therapy and have experienced disease progression confirmed by imaging (including but not limited to systemic chemotherapy, targeted therapy, immunotherapy, etc.), have been evaluated by the researchers to have refused other standard treatments at the time of enrollment, or have been determined by the researchers to have difficulty benefiting from treatments recommended by domestic and foreign clinical guidelines or expert consensus.
- 5: At least one tumor lesion has not received radiation therapy or other local treatments within 28 days. Moreover, according to the researchers' judgment, at least 2 intact tumor puncture samples with a length of ≥ 2cm can be obtained through surgical resection or puncture, which can be from different lesions, for the preparation of BST06 cells;
- 6: After TIL sampling, there should be at least one measurable lesion that meets the mRECIST standard definition (RECIST 1.1 standard for subjects without intrahepatic lesions);
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- 7: Eastern Cooperative Oncology Group (ECOG) score ≤ 1 point;
- 8: Child Pugh liver function grading score A-B7
- 9: HBsAg positive patients must meet the requirement of HBV DNA quantification<1 * 104 IU/ml (or 5 * 104 copy/ml) or receive at least one week of anti HBV treatment with a 10 fold reduction in viral index before the start of the study
- 10: Expected survival time ≥ 3 months;
- 11: During the screening and preparation period (within 14 days prior to TIL sampling), sufficient organ and bone marrow function was assessed
- 12: Prior to TIL sampling, adverse reactions caused by previous treatments had already recovered to the Common Adverse Event Evaluation Criteria (CTCAE) of 5.0 ≤ 2 (excluding toxicity judged by researchers to have no safety risk, such as hair loss or peripheral neurotoxicity of grade 2 or below);
- 13: From signing the informed consent form to agreeing to take effective contraceptive measures within 6 months after BST06 cell transfusion (subjects must use non pharmacological contraception);
- 14: Those who fully understand this experiment and voluntarily sign the informed consent form, and are able to comply with the visit and related procedures specified in the protocol.
Who cannot join
- 1: Pregnant or lactating women;
- 2: Subjects with a history of severe allergies and allergies to experimental drugs including but not limited to cyclophosphamide, fludarabine, BST06 injection components, etc;
- 3: Past or current presence of hepatic encephalopathy; Known patients with untreated or uncontrolled central nervous system metastases; Except for those who have received treatment and have stable symptoms, and have stopped glucocorticoid and anticonvulsant drug treatment for ≥ 4 weeks before pre-treatment;
- 4: At present, clinically significant ascites exists, defined as ascites with positive physical examination signs or requiring intervention treatment control (only those with imaging showing ascites without intervention can be included);
- 5: The proportion of liver tumors is ≥ 50%. For subjects planning to undergo liver lesion resection for specimen collection and preparation, the indocyanine green 15 minute retention rate (ICG-R15) must be ≥ 30%;
- 6: Organ transplantation, history of hematopoietic stem cell transplantation;
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- 7: Other serious diseases that may restrict participants from participating in this trial;
- 8: HIV positive, or positive for Treponema pallidum antibody; For patients with active hepatitis B or C, it is recommended to continue taking antiviral drugs during the study period. Active hepatitis B is defined as: positive hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and HBV-DNA>10000 IU/ml. Active hepatitis C is defined as HCV RNA above the lower limit of detection;
- 9: Within the 4 weeks prior to TIL sampling, any immunosuppressive drugs such as corticosteroids were used, or it was determined by the researcher that there were comorbidities that required the use of immunosuppressive drugs during the trial period. But it is allowed to use physiological doses of glucocorticoids (i.e. not exceeding 15mg/day of prednisone or equivalent doses of other glucocorticoids), and inhaled, intranasal, topical, or prophylactic corticosteroids are allowed to be used for contrast agent allergies;
- 10: Received local treatments such as interventional therapy, radiotherapy, ablation, as well as systemic treatments (including small molecule targeting, anti-PD-1/PD-L1 monoclonal antibodies, and chemotherapy) within 4 weeks prior to pre-treatment. Or received thymosin, interferon and other immunotherapy or any Chinese herbal medicine or traditional Chinese patent medicines and simple preparations for tumor control within 1 week before pretreatment;
- 11: Individuals who have received a live vaccine within the first 3 months of screening or plan to receive a live vaccine during the trial period
- 12: Individuals who have undergone major surgery (≥ grade 3 surgery) within the 4 weeks prior to screening, or who require elective surgery during the trial period (excluding TIL sampling surgery);
- 13: Patients who experience surgical complications or delayed wound healing prior to pre-treatment, and who have been assessed by researchers to increase the risk of gonorrhea, TIL treatment, or infection;
- 14: Diagnosed within 5 years prior to screening as coexisting with other primary malignant tumors, excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection;
- 15: Received cell therapy products within 6 months prior to pre-treatment;
- 16: Known cases of alcohol abuse, drug use, or substance abuse, as well as those deemed unsuitable by other researchers to participate in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects. This study plans to apply Bayesian Optimal Interval (BOIN) design, with at least 2 and up to 8 DLT assessable subjects in each dose group, who must complete a 28 day DLT assessment period. The study plan includes 2 dose groups: 5x10 ^ 9 and 3x10 ^ 10 BST06 cells
Read the detailed description
Main purpose:
Evaluate the safety and tolerability of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects.
Secondary purpose:
- Evaluate the preliminary effectiveness of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects:
- Evaluate the pharmacokinetic (PK) characteristics of BST06 injection.
Exploratory purpose:
Explore the Pharmacodynamics (PD) characteristics of BST06 injection.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Group A, Group B
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ABiological
3.0 × 10 ^ 9 BST06 cells, intravenous infusion，at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled
Group BBiological
3.0 × 10 ^ 10 BST06 cells, intravenous infusion, at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled
| Study group | Role | What they receive |
|---|---|---|
| BST06 | Experimental | intravenous infusion Receives: Biological: Group A; Biological: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
DLT is defined as the following adverse events related to the investigational drug(definitely related, likely related,possibly related) that occur within 28 days after administration of BST08 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)
Measured: From the infusion (Day 0) to Day 28
Maximum ToleratedDose(MTD)
The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BST08 administration and completed DLT observation)
Measured: From the infusion (Day 0) to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start30 Nov 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSyngen Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South China Hospital of Shenzhen University
- Responsible party
- Sponsor
- Investigators
- Mingyong Han, PhD, Principal investigator, South China Hospital of Shenzhen UnivercityYuqing Li, PhD, Principal investigator, South China Hospital of Shenzhen Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645314
- Sponsor's protocol ID
- BR-BST06-001
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of BST06 Injection in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06645314
- Acronym / sponsor ID
- BR-BST06-001
- Conditions
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- BioSyngen Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- South China Hospital of Shenzhen University
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Oct 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 study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects. This study plans to apply Bayesian Optimal Interval (BOIN) design, with at least 2 and up to 8 DLT assessable subjects in each dose group, who must complete a 28 day DLT assessment period. The study plan includes 2 dose groups: 5x10 ^ 9 and 3x10 ^ 10 BST06 cells
Detailed description
Main purpose:
Evaluate the safety and tolerability of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects.
Secondary purpose:
- Evaluate the preliminary effectiveness of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects:
- Evaluate the pharmacokinetic (PK) characteristics of BST06 injection.
Exploratory purpose:
Explore the Pharmacodynamics (PD) characteristics of BST06 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BST06 | Experimental | Biological: Group A, Biological: Group Bintravenous infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1: The age range is 18-70 years old (including the critical value);
- 2: HCC patients diagnosed by histopathological or cytological examination, or those who meet the criteria of the American Association for the Study of the Liver (AASLD) or are clinically diagnosed with hepatocellular carcinoma according to the "2022 Guidelines for the Diagnosis and Treatment of Primary Liver Cancer";
- 3: Tumor tissue pathology immunohistochemistry GPC3 positive;
- 4: Patients who have undergone at least first-line systemic therapy and have experienced disease progression confirmed by imaging (including but not limited to systemic chemotherapy, targeted therapy, immunotherapy, etc.), have been evaluated by the researchers to have refused other standard treatments at the time of enrollment, or have been determined by the researchers to have difficulty benefiting from treatments recommended by domestic and foreign clinical guidelines or expert consensus.
- 5: At least one tumor lesion has not received radiation therapy or other local treatments within 28 days. Moreover, according to the researchers' judgment, at least 2 intact tumor puncture samples with a length of ≥ 2cm can be obtained through surgical resection or puncture, which can be from different lesions, for the preparation of BST06 cells;
Key exclusion criteria (16 listed)
- 1: Pregnant or lactating women;
- 2: Subjects with a history of severe allergies and allergies to experimental drugs including but not limited to cyclophosphamide, fludarabine, BST06 injection components, etc;
- 3: Past or current presence of hepatic encephalopathy; Known patients with untreated or uncontrolled central nervous system metastases; Except for those who have received treatment and have stable symptoms, and have stopped glucocorticoid and anticonvulsant drug treatment for ≥ 4 weeks before pre-treatment;
- 4: At present, clinically significant ascites exists, defined as ascites with positive physical examination signs or requiring intervention treatment control (only those with imaging showing ascites without intervention can be included);
- 5: The proportion of liver tumors is ≥ 50%. For subjects planning to undergo liver lesion resection for specimen collection and preparation, the indocyanine green 15 minute retention rate (ICG-R15) must be ≥ 30%;
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 |
|---|---|---|
| Group A3.0 × 10 ^ 9 BST06 cells, intravenous infusion，at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled | Biological | BST06 |
| Group B3.0 × 10 ^ 10 BST06 cells, intravenous infusion, at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled | Biological | BST06 |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: From the infusion (Day 0) to Day 28
DLT is defined as the following adverse events related to the investigational drug(definitely related, likely related,possibly related) that occur within 28 days after administration of BST08 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)
Maximum ToleratedDose(MTD)
Time frame: From the infusion (Day 0) to Day 28
The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BST08 administration and completed DLT observation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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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.
Mingyong Han, PhD principal investigator
South China Hospital of Shenzhen Univercity
Yuqing Li, PhD principal investigator
South China Hospital of Shenzhen Univercity
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Group A and Group B in people with Hepatocellular Carcinoma, run by BioSyngen Pte Ltd.
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 14 inclusion and 16 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: opening soon, as of the sponsor's last update on 16 Oct 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?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqing Li, PhD (15018487211, liyu2t@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: From the infusion (Day 0) to Day 28). The study lists 2 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 16 Oct 2024.