Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma
NCT07648069 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-06-15
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.
Conditions
- Soft Tissue Sarcoma (STS)
- Osteosarcoma
Interventions
- BIOLOGICAL
-
Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody
Neoantigen vaccine+ specific lymphocytes + anti-PD1 antibody
- BIOLOGICAL
-
Neoantigen vaccine + anti-PD1 antibody
Neoantigen vaccine + anti-PD1 antibody
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-03
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-30
Countries
- China
Study Locations
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