A Phase 1 Study of BST02 in Treating Locally Advanced Liver Cancer
NCT06526832 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2024-07-30
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
- Locally Advanced Liver Carcinoma
Interventions
- BIOLOGICAL
-
BST02
BST02 is a tumor infiltrating lymphocyte product manufactured from the sample collected in the patient's tumor lesion.
Sponsors & Collaborators
-
BioSyngen Pte Ltd
lead INDUSTRY
Principal Investigators
-
Yaojun Zhang, Doctor · Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-04
- Primary Completion
- 2025-07-03
- Completion
- 2025-12-03
- FDA Drug
- Yes
Countries
- China
Study Locations
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