drugset / Trial / NCT05631886
Combination of CAR-DC Vaccine and ICIs in Malignant Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of TP53-EphA-2-CAR-DC vaccine; detect T cell response against TP53 mutant peptide and tumor neoepitopes after the treatment with TP53-EphA-2-CAR-DC vaccine and ICIs.
Timeline
- Start
- 2023-07-04
- Primary completion
- 2025-12-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TP53-EphA-2-CAR-DC | Cell therapy | 5e+06 cells | Intravenous |
| Subject | TP53-EphA-2-CAR-DC | Cell therapy | 1e+07 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |