drugset / Trial / NCT07648069

Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma

NCT07648069

Phase 1 Recruiting 16 enrolled Sun Yat-sen University
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

EvaluationDrugModalityDoseRoute
Subject Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody Cell therapy
Subject SarcVac Vaccine 0.5 ml Subcutaneous
Background Sintilimab Monoclonal antibody Intravenous