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
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ClinicalTrials.gov Identifier: NCT06173726 |
Recruitment Status :
Not yet recruiting
First Posted : December 18, 2023
Last Update Posted : December 18, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 29, 2023 | ||||||
First Posted Date ICMJE | December 18, 2023 | ||||||
Last Update Posted Date | December 18, 2023 | ||||||
Estimated Study Start Date ICMJE | December 5, 2023 | ||||||
Estimated Primary Completion Date | December 5, 2026 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | 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 | ||||||
Official Title ICMJE | 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 | ||||||
Brief 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. 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 |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Early Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Locally Advanced/Metastatic Liver Cancer | ||||||
Intervention ICMJE | Biological: BST02 Injection
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 |
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Study Arms ICMJE | Experimental: BST02 Injection
Intervention: Biological: BST02 Injection
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
6 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 5, 2026 | ||||||
Estimated Primary Completion Date | December 5, 2026 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | |||||||
Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT06173726 | ||||||
Other Study ID Numbers ICMJE | BIOSG-BST02-00 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | BioSyngen Pte Ltd | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | BioSyngen Pte Ltd | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Shenzhen Second People's Hospital | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | BioSyngen Pte Ltd | ||||||
Verification Date | December 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |