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

June 12, 2026 updated by: Xing Zhang, Sun Yat-sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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 :

  1. White blood cell count ≥ 3.0 × 109 / L;
  2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
  3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
  4. platelet ( PLT ) ≥ 75 × 109 / L;
  5. hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ;
  6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
  7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
  8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min;
  9. Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN;
  10. Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN;
  11. 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.

Exclusion Criteria:

  • 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 :

  1. White blood cell count ≥ 3.0 × 109 / L;
  2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
  3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
  4. platelet ( PLT ) ≥ 75 × 109 / L;
  5. hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ;
  6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
  7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
  8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min;
  9. Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN;
  10. Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN;
  11. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody
Neoantigen vaccine+ specific lymphocytes + anti-PD1 antibody
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.
Biological: Neoantigen vaccine + anti-PD1 antibody
Neoantigen vaccine + anti-PD1 antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events
Time Frame: 120 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 270 days
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.
270 days
DCR
Time Frame: 270 days
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.
270 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SunYat-senU-T2023-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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