To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors

January 20, 2020 updated by: Zhujiang Hospital

Application of NY-ESO-1-specific TCR Affinity Enhancing Specific T Cell Therapy (TAEST16001) in Solid Tumors Except Non Small Cell Lung Cancer,Including Liver Cancer,Gastric Cancer,Esophageal Cancer and so on.

The main purpose of this trial is to investigate the safety and tolerability of TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: human leukocyte antigens (HLA)-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 and 55% melanoma had benefits, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy. The US FDA has granted breakthrough TCR-T cell therapy for patients with inoperable or metastatic synovial sarcoma. The European Medicines Agency has also approved the same therapy to Priority Medicines(PRIME).

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. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on other solid tumors is still unknown. So we plan to explore its efficacy in many types of solid tumors.

The trial is to investigate the safety and tolerability of TAEST16001 cell therapy in multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: HLA-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • 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 Locations

  • China
    • Guang Dong
      • Guangzhou, Guang Dong, China, 510282
        • Zhujiang Hospital of Southern Mediacl University

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

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sign an informed consent before undertaking any trial-related activities;
  • ≥18 and ≤75 years old;
  • Multi-line treatment failed Solid Tumors except non small cell lung cancer,including Liver Cancer,Gastric Cancer,Esophageal Cancer,Bone and Soft Tissue Tumors,Breast Cancer, Bladder Carcinoma,Prostate Carcinoma,Thyroid Cancer, Ovarian Cancer and so on diagnosed by licensed pathologist;
  • multi-line treatment failed patients;
  • with measurable lesions according to Response Evaluation Criteria In Solid Tumors1.1 or immune related response criteria standard;
  • meet the two screening indicators: HLA-A*0201+, 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); blood platelet≥75 ×10^9/L; Hemoglobin≥10g/dL (No transfusion in the last 7 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; 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 (expect that the subject has Gilbert's syndrome).

  • no pregnant women；female patients must use contraceptive measures during the study and prohibit any homosexual or heterosexual;
  • The patients can regularly visit the research institutions for related tests, evaluations, and management during the study period.

Exclusion Criteria:

  • lung cancer ;
  • received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy 4 weeks before enrollment;
  • allergic to ingredients in this trial;
  • common terminology criteria for adverse events ≥2 because of the previous surgery or treatment-related adverse reactions;
  • with two types of primary solid tumors;
  • 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;
  • 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 central nervous system metastasis but not receive treatment;
  • with uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure;
  • alcohol and / or drug abuse;
  • pregnant or lactating women;
  • received concomitant medication prohibited by this trial;
  • with any medical condition or disease determined by the investigators that may be detrimental to this trial;
  • without legal capacity / limited behavior.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAEST16001
Patients who meet the inclusion criteria receive TAEST16001treatment after lymphodepleting by fludarabine and cyclophosphamide.
Drug: TAEST16001
After completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: 28 Days
The treatment-related adverse events of the patients received TAEST16001 treatment will be assessed by CTCAE v4.03
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess overall response rate
Time Frame: 270 Days
The overall response rate is evaluated according to Response Evaluation Criteria In Solid Tumors or Immune Related Response Criteria
270 Days
assess duration of response
Time Frame: 270 Days
The efficacy of TAEST16001 will be assessed by duration of response(DOR).The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
270 Days
assess time to progress
Time Frame: 270 Days
The efficacy of TAEST16001 will be assessed by time to progress (TTP).The TTP refers to the time from treatment to disease progression
270 Days
assess progression free survival
Time Frame: 270 Days
The efficacy of TAEST16001 will be assessed by progression free survival (PFS).The PFS refers to the time from treatment to progressive disease or death for any reason
270 Days
assess overall survival
Time Frame: 270 Days
The efficacy of TAEST16001 will be assessed by overall survival (OS).The OS refers to the time from treatment to death
270 Days
assess the expression of tumor markers
Time Frame: 270 Days
The efficacy of TAEST16001 will be assessed by tumor markers including carcinoembryonic antigen,carbohydrate antigen199,carbohydrate antigen125,prostate specific antigen,alpha fetoprotein,carbohydrate antigen724.
270 Days

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Collaborators

Guangdong Xiangxue Precision Medical Technology Co., Ltd.
Xiangxue Life Science Research Center
Xiangxue Pharmaceutical

Investigators

  • Study Chair: Jian Zhang, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 14, 2017

Primary Completion (Actual)

June 4, 2019

Study Completion (Actual)

June 4, 2019

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 20, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-ZLZX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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