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

Sponsor
Sun Yat-sen University
Study ID
NCT07648069
Phase
PHASE1
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Soft Tissue Sarcoma (STS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody — BIOLOGICAL
    Neoantigen vaccine+ specific lymphocytes + anti-PD1 antibody
  • Neoantigen vaccine + anti-PD1 antibody — BIOLOGICAL
    Neoantigen vaccine + anti-PD1 antibody

Study Details

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.

Key Dates

First listed
Jun 15, 2026
Start date
Sep 3, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug delivery mode 1
    1. Neoantigen Vaccine Injection: Each subject receives injections of vaccine components determined from prior in vitro experiments throughout the treatment course. The SarcVac peptide vaccine, mixed with an adjuvant (PolyI:C) in 0.5 ml of saline, is administered subcutaneously in the inguinal region on days 1, 3, 7, 15, 30, 65, and 86 from treatment initiation. 2. Tumor-Specific Lymphocyte Infusion: Throughout the treatment course, each subject receives tumor-specific lymphocyte infusions. 3. Antibody Therapy: Subjects receive anti-PD-1 antibody (Sintilimab) via intravenous infusion throughout the treatment period.
  • Experimental: Drug delivery mode 2
    1. Neoantigen Vaccine Injection: Each subject receives injections of vaccine components determined from prior in vitro experiments throughout the treatment course. The SarcVac peptide vaccine, mixed with an adjuvant (PolyI:C) in 0.5 ml of saline, is administered subcutaneously in the inguinal region on days 1, 3, 7, 15, 30, 65, and 86 from treatment initiation. 2. Antibody Therapy: Subjects receive anti-PD-1 antibody (Sintilimab) via intravenous infusion throughout the treatment period.

Primary Outcome Measure

Incidence and severity of adverse events [ Time Frame: 120 days ]

Central Contacts

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