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

NCT07648069 | Recruiting Phase 1 DMC

• 1 other identifier: SunYat-senU-T2023-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  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.

  120 days

Secondary Outcomes (2)

• ORR

  270 days

• DCR

  270 days

Study Arms (2)

Drug delivery mode 1

EXPERIMENTAL

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.

Biological: Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody

Drug delivery mode 2

EXPERIMENTAL

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.

Biological: Neoantigen vaccine + anti-PD1 antibody

Interventions

Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody BIOLOGICAL

Neoantigen vaccine+ specific lymphocytes + anti-PD1 antibody

Drug delivery mode 1

Neoantigen vaccine + anti-PD1 antibody BIOLOGICAL

Neoantigen vaccine + anti-PD1 antibody

Drug delivery mode 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
• Age≥18 years old, and≤70 years old ;
• Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ;
• Patients with first-line treatment failure ;
• No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ;
• According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ;
• The following three screening indicators should be met in the test screening period:
• （1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression.
• ( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators :
• White blood cell count ≥ 3.0 × 109 / L;
• absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
• absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
• platelet ( PLT ) ≥ 75 × 109 / L;
• hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ;
• Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;

You may not qualify if:

• \. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
• \. Age≥18 years old, and≤70 years old ; 3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ; 4. Patients with first-line treatment failure ; 5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ; 6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ; 7. The following three screening indicators should be met in the test screening period:
• （1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression.
• ( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators :
• White blood cell count ≥ 3.0 × 109 / L;
• absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
• absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
• platelet ( PLT ) ≥ 75 × 109 / L;
• hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ;
• Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
• partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
• serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min;
• Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN;
• Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN;
• total bilirubin ( TBIL ) ≤ 1 × ULN 13. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment; 14. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Sarcoma; Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Central Study Contacts

Zhang

CONTACT

86-020-87343192; zhangxing@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: September 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-04

Locations

CN (1)