B010-A Injection for Treating Patients With GPC3 Positive Advanced Hepatocellular Carcinoma
NCT05070156 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2023-12-15
Summary
This is an Open-label, Single Arm study to observe the safety and tolerability of B010-A in the treatment of advanced hepatocellular carcinoma.
Conditions
Interventions
- BIOLOGICAL
-
Biological/Vaccine: Low-dose group
1.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
- BIOLOGICAL
-
Biological/Vaccine: Mid-dose group
2.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
- BIOLOGICAL
-
Biological/Vaccine: High-dose group
3.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
Sponsors & Collaborators
-
Shanghai Pharmaceuticals Holding Co., Ltd
collaborator INDUSTRY -
Tongji University
lead OTHER
Principal Investigators
-
Qing Xu · Shanghai 10th People's Hospital
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
- 2021-10-29
- Primary Completion
- 2024-08-31
- Completion
- 2024-09-30
Countries
- China
Study Locations
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