Trials / Unknown
UnknownNCT06526832
A Phase 1 Study of BST02 in Treating Locally Advanced Liver Cancer
A Phase 1, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability and Efficacy of BST02 in Treating Locally Advanced Liver Cancer
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- Sponsor
- BioSyngen Pte Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to investigate the BST02, a tumor infiltrating lymphocyte product, collected from the locally advanced liver cancer subjects The main questions it aims to answer are: 1. Safety and tolerability of BST02. 2. Preliminary efficacy of BST02. Participants will receive a cytoreductive surgery to collect samples for the manufacture of BST02. Participants will receive BST02 infusion followed by IL-2 infusion. Blood samples will be collected for the analysis of PK and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BST02 | BST02 is a tumor infiltrating lymphocyte product manufactured from the sample collected in the patient's tumor lesion. |
Timeline
- Start date
- 2024-07-04
- Primary completion
- 2025-07-03
- Completion
- 2025-12-03
- First posted
- 2024-07-30
- Last updated
- 2024-07-30
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06526832. Inclusion in this directory is not an endorsement.