Bone SarcomaPhase 1NCT03462316
NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma
A Phase 1 study testing NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy） in people with Bone Sarcoma and Soft Tissue Sarcoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The main purpose of this trial is to investigate the safety and tolerability of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone and soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Bone Sarcoma, Soft Tissue Sarcoma
- What is being tested?
- NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2018to 15 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sign an informed consent before undertaking any trial-related activities;
- Aged 14 to 70 years old;
- Patients withbone and soft tissue sarcoma in stage IV by licensed pathologist;
- First-line treatment failed advanced patients.
- With measurable lesions, the product of the two maximum vertical diameters should not be less than 5mm*5mm
- Meet the two screening indicators: HLA-A*0201+, NYESO-1+(≥25% by immunohistochemistry);
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- Eastern Cooperative Oncology Group score 0-1; life expectancy is longer than 3 months;
- The patient did not receive anti-tumor therapy within 4 weeks before enrollment;
- A brain metastasis patient in a stable condition for one month after anti-tumor therapy can be included;
- Left ventricular ejection fraction≥50%;
- Lab test results meet the following requirements: white blood cell count≥3.0×10^9/L; absolute neutrophil count≥1.5 ×10^9/L (No human granulocyte colony stimulating factor support); absolute lymphocyte count≥0.7×10^9/L;blood platelet≥75 ×10^9/L; Hemoglobin≥10g/dL (No transfusion in the last 14 days); Prothrombin time or International normalized rate ≤1.5×normal upper limit, except taking anticoagulant therapy; thrombin time≤1.5×normal upper limit, except taking anticoagulant therapy; Serum creatinine: 1.5mg /dL (or 132.6 microns /L)；a 24-hour creatinine clearance rate≥60mL/ min; Aspartate transaminase / serum glutamic oxaloacetic transaminase≤2.5 ×upper limit of normal; Alanine aminotransferase/ serum glutamate pyruvate transaminase≤2.5 ×upper limit of normal; total bilirubin≤1.5×upper limit of normal.
- In the case of liver metastasis, glutamate transaminase and glutamate alanine transaminase should be less than 5 x ULN
- Women of child-bearing age who have not undergone sterilization before menopause must agree to use effective contraceptive measures at least 30 days from the start of the study treatment to the last drug use, and serum pregnancy test is negative 14 days before the first treatment.
- Men who have not received sterilization must agree to use effective contraception from the start of the study until at least 90 days after the last study medication is administered.
- During the whole test period, the subjects can regularly go to the enrolled research institutions for relevant detection, evaluation and management.
Who cannot join
- other types of tumors; If the patient has a previous history of malignant tumor, the disease-free time of the patient needs > for 5 years.
- received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy within 4 weeks before enrollment;
- allergic to ingredients in this trial;
- common terminology criteria for adverse events not return to under 2 level from previous surgery or treatment-related adverse reactions;
- poorly managed hypertension (systolic blood pressure >160 mmHg and / or diastolic blood pressure > 90 mmHg) or clinically serious (for example, active) cerebrovascular diseases such as cerebrovascular incident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months prior to signing the informed consent), unstable angina, grade II or above heart failure according to New York Heart Association Grading Congestive, or severe arrhythmia can not be controlled by medication or has a potential impact on the study; with consecutive three times of obvious abnormality on electrocardiogram or average QT corrected interval ≥450 millisecond;
- combined with other serious organic and mental disorders;
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- serious or active bacteria, viral or fungal infections that require systemic treatment;
- with autoimmune diseases: such as a history of inflammatory bowel disease or other autoimmune diseases determined by the investigator as unsuitable for the study (e.g. systemic lupus erythematosus,vasculitis, invasive pulmonary disease);
- within 4 weeks prior the infusion, received chronic systemic steroid cortisone, hydroxyurea, immunomodulatory treatment (for example: Interleukin 2, alpha or gamma interferon, granulocyte colony stimulating factor, mammalian target of rapamycin inhibitors, cyclosporine, Thymosin etc);
- with organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy;
- with uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure;
- alcohol and / or drug abuse;
- pregnant or lactating women;
- with any medical condition or disease determined by the investigators that may be detrimental to this trial;
- without legal capacity / limited behavior.
- receive any other gene therapy products before study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor (TCR) Affinity Enhancing Specific T Cell in Bone and Soft Tissue Sarcoma
The main purpose of this trial is to investigate the safety and tolerability of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone and soft tissue sarcoma. The secondary purpose of this trial is to investigate the efficacy of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone and soft tissue sarcoma.
Read the detailed description
This is a one arm, open label, dose escalation, single dose phase I study. The investigators include first-line treatment failed advanced patients with bone or soft tissue sarcoma and without standard regimen;TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute, showed that 61% Synovial cell sarcoma patients and 55% melanoma patients benefit from this treatment, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy.
This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. NY-ESO-1 expression was also found in 88.2% of myxoid liposarcomas, 61.1% of synovial sarcomas, 31.3% of osteosarcomas, 21.4% of pleomorphic liposarcomas, 16.7% of desmoplastic small round cell tumors, and 14.3% of chondrosarcomas. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on bone and soft tissue sarcoma is still unknown. So the investigators plan to explore its efficacy.
The patients must meet the two criteria: HLA-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry. By this trial, the dose-limiting toxicity (DLT) and maximum tolerance (MTD) will be initially identified.
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma
- Being tested
- NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）
- Medical subject headings
- Bone Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）Biological
NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）
| Study group | Role | What they receive |
|---|---|---|
| NY-ESO-1 TCR Specific T cell Therapy | Experimental | NY-ESO-1 TCR specific T cells are prepared by lentiviral infection. Seven days before TCR-T cell reinfusion, the subjects received low-dose cyclophosphamide (15mg/kg/d x 3 days) and low-dose fludarabine (15mg/m2/d x 3 days) lymphocyte clearance. Four days later, TCR-T cells were transfused back (1 x 109-5 x 1010 was administered once or in stages). Then interleukin (IL)-2 subcutaneous injections (250,000 IU/twice/day) will be subcutaneously administered for 14 days concomitantly to each subject within 15-30 minutes after cell reinfusion. If the first three patients had no severe bone marrow suppression side effects (CTCAE was above grade 3) on low-dose lymphocyte clearance therapy, the dosage of cyclophosphamide (20 mg/kg/d x 3 days) and fludarabine (25 mg/m2/d x 3 days) could be increased for follow-up patients. Receives: Biological: NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0
safety evaluation(dose-limiting toxicity and the maximum tolerance)
Measured: 270 days
Secondary outcomes (1)
clinical response rate
Overall Response Rate as assessed by RECIST criteria
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 posted12 Mar 2018
- Study start21 May 2018
- Primary completion15 Apr 2020
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone SarcomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Xiangxue Precision Medical Technology Co., Ltd.
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462316
- Sponsor's protocol ID
- B2017-023-01
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2018
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
PubMed 31401903
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor (TCR) Affinity Enhancing Specific T Cell in Bone and Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03462316
- Acronym / sponsor ID
- B2017-023-01
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Xiangxue Precision Medical Technology Co., Ltd.
- Study start
- 21 May 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this trial is to investigate the safety and tolerability of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone and soft tissue sarcoma. The secondary purpose of this trial is to investigate the efficacy of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone and soft tissue sarcoma.
Detailed description
This is a one arm, open label, dose escalation, single dose phase I study. The investigators include first-line treatment failed advanced patients with bone or soft tissue sarcoma and without standard regimen;TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute, showed that 61% Synovial cell sarcoma patients and 55% melanoma patients benefit from this treatment, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy.
This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. NY-ESO-1 expression was also found in 88.2% of myxoid liposarcomas, 61.1% of synovial sarcomas, 31.3% of osteosarcomas, 21.4% of pleomorphic liposarcomas, 16.7% of desmoplastic small round cell tumors, and 14.3% of chondrosarcomas. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on bone and soft tissue sarcoma is still unknown. So the investigators plan to explore its efficacy.
The patients must meet the two criteria: HLA-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry. By this trial, the dose-limiting toxicity (DLT) and maximum tolerance (MTD) will be initially identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NY-ESO-1 TCR Specific T cell Therapy | Experimental | Biological: NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）NY-ESO-1 TCR specific T cells are prepared by lentiviral infection. Seven days before TCR-T cell reinfusion, the subjects received low-dose cyclophosphamide (15mg/kg/d x 3 days) and low-dose fludarabine (15mg/m2/d x 3 days) lymphocyte clearance. Four days later, TCR-T cells were transfused back (1 x 109-5 x 1010 was administered once or in stages). Then interleukin (IL)-2 subcutaneous injections (250,000 IU/twice/day) will be subcutaneously administered for 14 days concomitantly to each subject within 15-30 minutes after cell reinfusion. If the first three patients had no severe bone marrow suppression side effects (CTCAE was above grade 3) on low-dose lymphocyte clearance therapy, the dosage of cyclophosphamide (20 mg/kg/d x 3 days) and fludarabine (25 mg/m2/d x 3 days) could be increased for follow-up patients. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Sign an informed consent before undertaking any trial-related activities;
- Aged 14 to 70 years old;
- Patients withbone and soft tissue sarcoma in stage IV by licensed pathologist;
- First-line treatment failed advanced patients.
- With measurable lesions, the product of the two maximum vertical diameters should not be less than 5mm*5mm
Key exclusion criteria (16 listed)
- other types of tumors; If the patient has a previous history of malignant tumor, the disease-free time of the patient needs > for 5 years.
- received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy within 4 weeks before enrollment;
- allergic to ingredients in this trial;
- common terminology criteria for adverse events not return to under 2 level from previous surgery or treatment-related adverse reactions;
- poorly managed hypertension (systolic blood pressure >160 mmHg and / or diastolic blood pressure > 90 mmHg) or clinically serious (for example, active) cerebrovascular diseases such as cerebrovascular incident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months prior to signing the informed consent), unstable angina, grade II or above heart failure according to New York Heart Association Grading Congestive, or severe arrhythmia can not be controlled by medication or has a potential impact on the study; with consecutive three times of obvious abnormality on electrocardiogram or average QT corrected interval ≥450 millisecond;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy） | Biological | NY-ESO-1 TCR Specific T cell Therapy |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0
Time frame: 270 days
safety evaluation(dose-limiting toxicity and the maximum tolerance)
1 secondary outcome
clinical response rate
Time frame: 270 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 31401903Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy） in people with Bone Sarcoma and Soft Tissue Sarcoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0 (time frame: 270 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.