Soft Tissue Sarcoma (STS)Phase 1NCT07648069
Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma
A Phase 1 study testing Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody and Neoantigen vaccine + anti-PD1 antibody in people with Soft Tissue Sarcoma (STS) and Osteosarcoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma (STS), Osteosarcoma
- What is being tested?
- Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody and Neoantigen vaccine + anti-PD1 antibody
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to 30 Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
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- 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.
Who cannot join
- 1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
- 2. 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 ) ;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Zhang, 86-020-87343192, zhangxing@sysucc.org.cn
About this study
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.
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.
Read the detailed description
Soft tissue sarcoma (STS) represents a heterogeneous group of malignant tumors. The prognosis is poor with an overall survival of 12-19 months for patients with metastasis. A critical unmet medical need is to develop novel and effective therapeutic approaches to improve the survival of patients with STS, for whom limited alternative chemotherapeutic or targeting regimens are available.
In recent years, tumor immunotherapy has emerged as a promising alternative to traditional treatments like surgery, chemotherapy, and radiotherapy. This approach includes four primary categories: immune checkpoint blockade, immunomodulators, adoptive cell transfer, and tumor vaccines. Immune checkpoint inhibitors, such as PD-1/PD-L1 and CTLA-4 antibodies, have shown efficacy in treating certain cancers. Tumor vaccines, which utilize tumor antigens to stimulate specific immune responses against cancer cells, offer notable advantages. These vaccines are characterized by low toxicity, high specificity, and the ability to induce immune memory, thereby reducing the risk of recurrence. Tumor-specific lymphocytes further enhance the immune system's capacity to target and kill tumor cells directly.
This study utilizes next-generation sequencing technology and bioinformatics analysis to accurately identify personalized tumor neoantigens. By screening for neoantigens with high MHC affinity and strong immunogenicity, we develop a personalized neoantigen vaccine, SarcVac. Subsequently, these neoantigens are used in vitro to activate and expand the patient's peripheral blood lymphocytes, yielding tumor-specific lymphocytes. This clinical trial will assess the safety and tolerability of the neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes, in patients with advanced solid tumors. Additionally, a preliminary assessment of its efficacy will be conducted.
- Conditions
- Soft Tissue Sarcoma (STS), Osteosarcoma
- Being tested
- Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody, Neoantigen vaccine + anti-PD1 antibody
- Medical subject headings
- Sarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen vaccine + specific lymphocytes + anti-PD1 antibodyBiological
Neoantigen vaccine+ specific lymphocytes + anti-PD1 antibody
Neoantigen vaccine + anti-PD1 antibodyBiological
Neoantigen vaccine + anti-PD1 antibody
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Neoantigen vaccine + anti-PD1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days
Secondary outcomes (2)
ORR
The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, and to evaluate whether the vaccine's efficacy demonstrates dose dependency.
Measured: 270 days
DCR
The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, and to evaluate whether the vaccine's efficacy demonstrates dose dependency.
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start3 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (STS)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648069
- Sponsor's protocol ID
- SunYat-senU-T2023-002
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No