Trials / Completed
CompletedNCT03884751
Chimeric Antigen Receptor T Cells Targeting Glypican-3
A Phase I Clinical Study of Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CAR-GPC3 T Cells) in Patients With Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- CARsgen Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I Clinical Study of Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CAR-GPC3 T Cells) in Patients with Advanced Hepatocellular Carcinoma
Detailed description
This is a phase I open-label, single-arm, multicenter clinical trial designed to observe and evaluate the safety, cell metabolokinetics, and efficacy of CAR-GPC3 T cells infused intravenously at single escalating doses in patients with advanced hepatocellular carcinoma. Primary objectives: \- To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at escalating doses in patients with advanced hepatocellular carcinoma. Secondary objectives： * To evaluate the metabolic kinetics of single infusion of CAR-GPC3 T cells * To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells * To observe the efficacy of CAR-GPC3 T cells in the treatment of advanced hepatocellular carcinoma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAR-GPC3 T Cells | CAR-GPC3 T Cells injection |
Timeline
- Start date
- 2019-08-15
- Primary completion
- 2021-05-28
- Completion
- 2021-12-03
- First posted
- 2019-03-21
- Last updated
- 2022-02-24
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03884751. Inclusion in this directory is not an endorsement.