Trials / Unknown
UnknownNCT04973098
Phase I Clinical Trial of CT0181 Cells in the Treatment of Hepatocellular Carcinoma
An Open-Label, Dose Escalation/Dose Exploration, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single/Multiple Infusion of CT0181 Injection in Patients With Advanced Hepatocellular Carcinoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- Sponsor
- Peking University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I Clinical Study of CT0181 cells in Patients with Advanced Hepatocellular Carcinoma
Detailed description
Primary objectives: Evaluate the safety and tolerance of CT0181 cells in patients with advanced hepatocellular carcinoma within 28 days after the first infusion Secondary objectives: Evaluate the metabolic kinetics of CT0181 cells ; Evaluate overall safety and tolerability ; Evaluate the initial efficacy of CT0181 cell infusion in the treatment of advanced hepatocellular carcinoma with positive Glypican-3（GPC3 ）expression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT0181 Cells | 5 dose levels each with or without lymphocyte clearance were tentatively determined. |
Timeline
- Start date
- 2021-08-05
- Primary completion
- 2022-08-01
- Completion
- 2023-06-01
- First posted
- 2021-07-22
- Last updated
- 2021-11-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04973098. Inclusion in this directory is not an endorsement.