Trials / Unknown
UnknownNCT06144385
A Phase 1, Single-arm, Open-label, Dose-escalation Study of JWATM204 as T Cell-targeted Immunotherapy in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd. · Industry
- 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 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 JWATM204 . During JWATM204 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 JWATM204 by intravenous (IV) injection. |
Timeline
- Start date
- 2022-03-24
- Primary completion
- 2024-03-01
- Completion
- 2024-12-01
- First posted
- 2023-11-22
- Last updated
- 2024-01-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06144385. Inclusion in this directory is not an endorsement.