NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma

STATUS

Recruiting
End date

Feb 15, 2023
participants needed

20
sponsor

Sun Yat-sen University

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Updated on 18 May 2022

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colony stimulating factor

metastasis

neutrophil count

g-csf

ny-eso-1

cellular therapy

soft tissue sarcoma

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. 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.

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.

Details

Condition	Bone Sarcoma, Soft Tissue Sarcoma
Treatment	NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）
Clinical Study Identifier	NCT03462316
Sponsor	Sun Yat-sen University
Last Modified on	18 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 5mm5mm
	Meet the two screening indicators: HLA-A0201+, NYESO-1+(≥25% by immunohistochemistry)
	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
Exclusion Criteria
	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
	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
	combined with other serious organic and mental disorders
	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

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NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma