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RECRUITING
NCT07648069
PHASE1

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: A Prospective, Single-center, Double-arm, Phase I Clinical Trial of Tumor Neoantigen Vaccine SarVac Combined With Tumor-specific Lymphocyte Reinfusion in the Treatment of Patients With Advanced or Unresectable Sarcoma-based Solid Tumors Who Failed Standard Treatment.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2024-09-03

Completion Date

2027-06-30

Last Updated

2026-06-15

Healthy Volunteers

No

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China