Trials / Recruiting
RecruitingNCT05926726
GPC3-directed CAR-T in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma
JWATM214，an Armored GPC3-directed CAR-T ，in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma ：a Single-arm, Open-label，Dose-escalation Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infused autologous armored GPC3-directed CAR-T in patients with advanced hepatocellular carcinoma refractory to prior systematic treatments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAR-GPC3 T cells | Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWATM214 . During JWATM214 production, subjects will receive a preconditioning chemotherapy regimen of cyclophosphamide and fludarabine to deplete the lymphocytes. After lymphodepletion, subjects will receive single-dose treatment with JWATM214 by intravenous (IV) injection. |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2023-07-03
- Last updated
- 2023-07-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05926726. Inclusion in this directory is not an endorsement.