Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma
Recruiting now · Phase 1
Conditions studied: Soft Tissue Sarcoma (STS), Osteosarcoma
In brief
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 facts
- Study ID
- NCT07648069
- Run by
- Sun Yat-sen University
- People needed
- 16
- Starts
- 2024-09-03
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
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;
- 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.
You may not qualify if…
- 1. 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.
Where it is running
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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