Locally Advanced/Metastatic Liver CancerEarly Phase 1NCT06173726
Investigator-initiated Phase I Exploratory Clinical Study of the Safety, Tolerability, and Efficacy of BST02 Injection in the Treatment of Locally Advanced/Metastatic Liver Cancer
A Early Phase 1 study testing BST02 Injection in people with Locally Advanced/Metastatic Liver Cancer, run by BioSyngen Pte Ltd at 1 site in China.
Trial summary
This is an open, single-arm, investigator-initiated Phase I clinical trial to evaluate the safety, tolerability, and initial efficacy of BST02 injection in patients with locally advanced / metastatic liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced/Metastatic Liver Cancer
- What is being tested?
- BST02 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 5 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old (including the critical value).
- Patients with histologically or cytologically confirmed locally advanced / metastatic liver cancer (including hepatocellular carcinoma, intrahepatic bile duct carcinoma, and metastatic liver cancer). Hepatocellular carcinoma (HCC) and cholangiocarcinoma (BCLC) are either stage C or stage B that is not suitable for local treatment/local treatment progression according to Barcelona Clinic Liver Cancer (BCLC). Metastatic liver cancer is not suitable for radical surgical treatment according to the TNM stage of the primary cancer.
- For locally advanced liver cancer, guidelines should recommend at least first-line systemic therapy (atrilizumab + bevacizumab, sindilizumab + bevacizumab analogues; Donafenib, Renvastinib, sorafenib; FOLFOX4) after failure (disease progression or intolerance), or as determined by the investigator to be unsuitable, or the patient refused to receive the standard treatment recommended by the guidelines. For metastatic liver cancer, failure (disease progression or intolerance) of at least second-line treatment recommended by guidelines, or inappropriate treatment determined by the investigator, or refusal of standard treatment is required.
- At least one operation without radiation or other local treatment within 28 days to remove the tumor lesion with an estimated lesion volume of at least 8 cm^3, excluding necrotic areas, for the preparation of BST02 cells.
- There is at least one measurable lesion after sampling that meets the definition of RECIST 1.1 standard, and the intrahepatic target lesion requires arterial phase enhanced imaging.
- The Eastern Cooperative Oncology Group (ECOG) score ≤1 score.
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- Child-Pugh score of cirrhosis ≤7 points.
- Expected survival time ≥3 months.
- Adequate organ and bone marrow function in the assessment conducted during the screening period (within 14 days prior to TIL sampling), as defined below:
- Blood routine: Absolute Neutrophil Count (ANC) ≥1.5×10^9/L, Blood Platelet count (PLT) ≥90×10^9/L, Hemoglobin (Hemoglobin, ANC) ≥1.5×10^9/L HGB) ≥80 g/L (no blood transfusion or erythropoietin treatment within 14 days).
- Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels ≤5× upper limit of normal value (ULN), Serum Total Bilirubin (TBil) ≤1.5×ULN, if diagnosed with Gilbert syndrome: TBil≤3×ULN.
- Coagulation function: Activated partial thromboplastin time (APTT) ≤1.5×ULN, while International Normalized Ratio, INR), Prothrombin Time (PT) ≤1.5×ULN.
- Renal function: Serum Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance (Ccr) ≥60 mL/min (Cockcroft-Gault formula).
- Cardiac function examination: Left ventricular Ejection Fraction (LVEF) ≥50% by echocardiography; No arrhythmias requiring treatment, Fridericia QT correction formulas (QTcF) ≤470 ms (QTcF is calculated using Fridericia's formula, That is, QTcF = QT/ (RR^0.33), RR is the standardized heart rate value, RR=60/ heart rate; If the first check is abnormal, the interval of at least 5 minutes, retest twice, take the comprehensive result/average value to judge the conformity);
- Lung function: FEV1 percentage of predicted value (FEV1%) ≥60%.
- Prior to tumor sampling, the adverse reactions caused by previous treatment had returned to the Common Adverse Event Evaluation Criteria (CTCAE) 5.0≤1 (except for alopecia, peripheral neurotoxicity of grade 2 or below, and other toxicities that the investigators judged to have no safety risk).
- Consent to take effective contraceptive measures within 6 months from the signing of informed consent to TIL cell transfusion (subjects must use non-drug contraceptive measures).
- Those who fully understand the test and voluntarily sign the informed consent and can comply with the visit and related procedures stipulated in the program.
- -
Who cannot join
- Pregnant or lactating women.
- Subjects with a history of severe allergy to the experimental drugs including but not limited to cyclophosphamide, fludarabine, IL-2, and TIL injection components.
- Patients with past or current hepatic encephalopathy, known to have other central nervous system metastases not effectively controlled by treatment or untreated, except those who have been treated and whose symptoms are stable, and who discontinue glucocorticoid and anticonvulsant therapy ≥4 weeks prior to preconditioning.
- There is currently clinically significant ascites, which are defined as ascites with positive signs of ascites in physical examination or requiring intervention treatment (only those who show ascites on imaging without intervention can be included).
- The proportion of liver occupied by tumor ≥50%, or ICG-R15≥30%.
- Organ transplantation, hematopoietic stem cell transplantation history;
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- Other serious medical conditions that may limit participants' participation in the study, including but not limited to:
- Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after medication).
- Poorly controlled diabetes: Fasting blood glucose levels remained above 11.1mmol/L after standard insulin treatment.
- Unstable cardiovascular and cerebrovascular diseases: uncontrolled congestive heart failure, myocardial infarction or unstable arrhythmia or unstable angina within the last 6 months, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism, deep vein thrombosis, etc.
- Poorly controlled respiratory diseases: pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease, etc.
- Active autoimmune diseases requiring systemic treatment during the study: Subjects with eczema, vitiligo, psoriasis, alopecia, or Grave's disease that will not require systemic treatment within the next 2 years, other autoimmune diseases that are not expected to recur, and type 1 diabetes requiring insulin replacement therapy only were enrolled.
- Have an active infection or active tuberculosis infection that requires systemic treatment.
- Mental illness, other than mild depression.
- HIV positive, or treponema pallidum antibody positive; Patients with active hepatitis B or C; Active hepatitis B is defined as hepatitis B core antibody (HBcAb) or Hepatitis B surface antigen (HBsAg) positive with HBV-DNA < 2000 IU/ml. HBsAg positive patients must receive antiviral treatment according to the "Chronic Hepatitis B Prevention and Treatment Guidelines 2019"; Active hepatitis C was defined as HCV RNA higher than the lower limit of detection.
- Use of any immunosuppressive drugs, such as corticosteroids, in the 4 weeks prior to the tumor tissue sampling, or the presence of co-existing diseases that the investigator determined required the use of immunosuppressive drugs during the trial. However, the use of physiological doses of corticosteroids (i.e., no more than 15mg/ day of prednisone or equivalent doses of other corticosteroids) is permitted, and the use of corticosteroids for inhalation, intranasal, topical or prophylactic use of contrast media allergies is permitted.
- Anti-tumor therapy was received before pretreatment, including anti-PD-1 / PD-L1 monoclonal antibodies, targeted drugs, chemotherapy, surgery, etc., and the last administration/treatment distance from pretreatment was less than 2 weeks. Or the above treatment-related adverse events, CTCAE classification does not return to grade 1 or stable.
- Those who have received live vaccine within 3 months prior to screening or plan to receive live vaccine during the trial.
- Those who had undergone major surgery within 4 weeks prior to screening or required elective surgery during the trial period (except TIL sampling).
- Patients who had surgical complications or delayed wound healing prior to pretreatment and were judged by the investigators to be at increased risk of eluviation, TIL therapy, IL-2 adjuvant therapy, or infection.
- diagnosed with other primary malignancies within 5 years prior to screening, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ.
- Known alcohol, drug, or substance abuse, and other subjects deemed unsuitable for participation in the study.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000
Liang Xiao, doctor, 13554764527, 9179320@qq.com
Liang Xiao, doctor
About this study
This is an open, single-arm, investigator-initiated Phase I clinical trial to evaluate the safety, tolerability, and initial efficacy of BST02 injection in patients with locally advanced / metastatic liver cancer. This study includes a dose escalation study and a dose extension study, which will observe the effects of different IL-2 injection doses on the safety and efficacy of BST02.
After signing the informed consent, the subjects will roughly go through two periods: the main study period and the long-term follow-up period. The main study period includes screening period, treatment and safety observation period, and follow-up period
- Conditions
- Locally Advanced/Metastatic Liver Cancer
- Being tested
- BST02 Injection
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BST02 InjectionBiological
The TIL used for tumor tissue surgical sampling of qualified subjects was used to prepare BST02 injection, and the subjects who successfully received the surgical sampling were considered to be enrolled.
In the study process, cell transfusions were recorded as day 0 of the study. On the 3rd day (D-3) before infusion of BST02 injection, it is necessary to receive eluvial pretreatment. Considering that this product is unmodified autologous T lymphocytes, previous studies have shown that low-intensity cyclophosphamide can stimulate their proliferation in vivo. Therefore, the cyclophosphamide (Cy) single-drug regimen is recommended: Cy 250mg~1.5g/m2, a single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| BST02 Injection | Experimental | Not described Receives: Biological: BST02 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Occurrence and incidence
Measured: Adverse events in D(0) to D(28) after BST02 cell reinfusion
Severe Adverse Event
Occurrence and incidence
Measured: Serious adverse events in D(0) to D(28) after BST02 cell reinfusion
Dose-Limiting Toxicity
Dose-Limiting Toxicity
Measured: Cell transfusion began until 28 days after cell transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start5 Dec 2023 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/Metastatic Liver CancerStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSyngen Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Second People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173726
- Sponsor's protocol ID
- BIOSG-BST02-00
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated Phase I Exploratory Clinical Study of the Safety, Tolerability, and Efficacy of BST02 Injection in the Treatment of Locally Advanced/Metastatic Liver Cancer
- ClinicalTrials.gov ID
- NCT06173726
- Acronym / sponsor ID
- BIOSG-BST02-00
- Conditions
- Locally Advanced/Metastatic Liver Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- BioSyngen Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shenzhen Second People's Hospital
- Study start
- 5 Dec 2023 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 18 Dec 2023 (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, single-arm, investigator-initiated Phase I clinical trial to evaluate the safety, tolerability, and initial efficacy of BST02 injection in patients with locally advanced / metastatic liver cancer. This study includes a dose escalation study and a dose extension study, which will observe the effects of different IL-2 injection doses on the safety and efficacy of BST02.
After signing the informed consent, the subjects will roughly go through two periods: the main study period and the long-term follow-up period. The main study period includes screening period, treatment and safety observation period, and follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BST02 Injection | Experimental | Biological: BST02 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18-75 years old (including the critical value).
- Patients with histologically or cytologically confirmed locally advanced / metastatic liver cancer (including hepatocellular carcinoma, intrahepatic bile duct carcinoma, and metastatic liver cancer). Hepatocellular carcinoma (HCC) and cholangiocarcinoma (BCLC) are either stage C or stage B that is not suitable for local treatment/local treatment progression according to Barcelona Clinic Liver Cancer (BCLC). Metastatic liver cancer is not suitable for radical surgical treatment according to the TNM stage of the primary cancer.
- For locally advanced liver cancer, guidelines should recommend at least first-line systemic therapy (atrilizumab + bevacizumab, sindilizumab + bevacizumab analogues; Donafenib, Renvastinib, sorafenib; FOLFOX4) after failure (disease progression or intolerance), or as determined by the investigator to be unsuitable, or the patient refused to receive the standard treatment recommended by the guidelines. For metastatic liver cancer, failure (disease progression or intolerance) of at least second-line treatment recommended by guidelines, or inappropriate treatment determined by the investigator, or refusal of standard treatment is required.
- At least one operation without radiation or other local treatment within 28 days to remove the tumor lesion with an estimated lesion volume of at least 8 cm^3, excluding necrotic areas, for the preparation of BST02 cells.
- There is at least one measurable lesion after sampling that meets the definition of RECIST 1.1 standard, and the intrahepatic target lesion requires arterial phase enhanced imaging.
Key exclusion criteria (23 listed)
- Pregnant or lactating women.
- Subjects with a history of severe allergy to the experimental drugs including but not limited to cyclophosphamide, fludarabine, IL-2, and TIL injection components.
- Patients with past or current hepatic encephalopathy, known to have other central nervous system metastases not effectively controlled by treatment or untreated, except those who have been treated and whose symptoms are stable, and who discontinue glucocorticoid and anticonvulsant therapy ≥4 weeks prior to preconditioning.
- There is currently clinically significant ascites, which are defined as ascites with positive signs of ascites in physical examination or requiring intervention treatment (only those who show ascites on imaging without intervention can be included).
- The proportion of liver occupied by tumor ≥50%, or ICG-R15≥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 |
|---|---|---|
| BST02 InjectionThe TIL used for tumor tissue surgical sampling of qualified subjects was used to prepare BST02 injection, and the subjects who successfully received the surgical sampling were considered to be enrolled. In the study process, cell transfusions were recorded as day 0 of the study. On the 3rd day (D-3) before infusion of BST02 injection, it is necessary to receive eluvial pretreatment. Considering that this product is unmodified autologous T lymphocytes, previous studies have shown that low-intensity cyclophosphamide can stimulate their proliferation in vivo. Therefore, the cyclophosphamide (Cy) single-drug regimen is recommended: Cy 250mg~1.5g/m2, a single intravenous infusion | Biological | BST02 Injection |
Primary outcome
Adverse Event
Time frame: Adverse events in D(0) to D(28) after BST02 cell reinfusion
Occurrence and incidence
Severe Adverse Event
Time frame: Serious adverse events in D(0) to D(28) after BST02 cell reinfusion
Occurrence and incidence
Dose-Limiting Toxicity
Time frame: Cell transfusion began until 28 days after cell transfusion
Dose-Limiting Toxicity
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 18 Dec 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BST02 Injection in people with Locally Advanced/Metastatic Liver Cancer, run by BioSyngen Pte Ltd at 1 site in China.
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 19 inclusion and 23 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 18 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: Adverse events in D(0) to D(28) after BST02 cell reinfusion). The study lists 3 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 18 Dec 2023.