drugset / Trial / NCT07648069
Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this trial is to evaluate the safety and tolerability of the tumor neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes, in patients with advanced bone and soft tissue sarcoma who have failed first-line treatment. The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, in these patients and to evaluate whether the vaccine's efficacy demonstrates dose dependency.
Timeline
- Start
- 2024-09-03
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody | Cell therapy | — | — |
| Subject | SarcVac | Vaccine | 0.5 ml | Subcutaneous |
| Background | Sintilimab | Monoclonal antibody | — | Intravenous |