Status:
UNKNOWN
TAEST16001 in the Treatment of Soft Tissue Sarcoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Guangdong Xiangxue Precision Medical Technology Co., Ltd.
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study is an open, single arm, dose increasing early clinical study, which is divided into two parts: "3 + 3" designed dose escalation study and extended group study. The purpose of this study is ...
Detailed Description
Immunotherapy is one of the most promising and effective methods to cure tumor besides operation, chemotherapy and radiotherapy. T cell therapy, which belongs to immunotherapy, mainly includes CAR-T (...
Eligibility Criteria
Inclusion
- The informed consent form (ICF) (genotype and tumor antigen screening and primary screening) should be signed before any research related operation;
- Age ≥ 18 years and ≤ 70 years;
- Advanced solid tumor with definite pathological diagnosis;
- Unresectable advanced solid tumor that fails to undergo standard treatment (disease progression or recurrence or intolerable, such as chemotherapy, radiotherapy, targeted treatment, etc.) or lacks effective treatment:
- 1\) Soft tissue sarcoma: a) Soft tissue sarcoma failed to be treated by chemotherapy containing doxorubicin and ifosfamide; 2) Primary liver cancer: a) Child Pugh liver function score A within 7 days before cell reinfusion; 3) Ovarian cancer: a) Platinum based chemotherapy (such as paclitaxel combined with carboplatin) failed. 4) Non small cell lung cancer (NSCLC): a) failure (disease progression or toxicity intolerance) or lack of effective treatment method of previous standard treatment (including platinum chemotherapy scheme or driven gene targeted treatment); 5) Breast cancer: a) patients who have received standard treatment failure or not applicable standard treatment.
- 5、At least 1 measurable lesion (according to recist1.1 standard） 6、Genotype and tumor antigen screening must meet the following two criteria: 1) HLA-A \* 02:01 positive; 2) NY-ESO-1 positive: immunohistochemistry positive cells ≥ 20%; 7、ECOG score 0-1 and expected survival time \> 3 months; 8. Color Doppler echocardiography indicates left ventricular ejection fraction ≥ 50%; 9. Laboratory test results should at least meet the following criteria:
- White blood cell count ≥ 3.0 × 109 / L
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L (without the support of G-CSF and GM-CSF, at least 14 days before CLT);
- Absolute lymphocyte count (ALC) ≥ 0.7 × 109 / L;
- Platelet (PLT) ≥ 75 × 109 / L (no transfusion treatment 14 days before CLT);
- Hemoglobin ≥ 10g / dl (no transfusion treatment 14 days before CLT);
- Prothrombin time international INR ≤ 1.5 × ULN, unless anticoagulant therapy is used;
- APTT ≤ 1.5 × ULN, unless anticoagulant therapy is used;
- Serum creatinine ≤ 1.5mg/dl (or 132.6 μ mol / L)
- Creatinine clearance ≥ 60ml / min;
- AST / SGOT ≤ 2.5 × ULN; - ALT / SGPT ≤ 2.5 × ULN; - TBIL ）≤1.5×ULN； 10、Women of childbearing age who have not undergone sterilization before menopause must agree to use effective contraceptive measures within one year from the beginning of study treatment (chemotherapy for clearing lymph nodes) to the end of cell transfusion, and the serum pregnancy test is negative within 14 days before the first cell transfusion.
- 11、Men who have not undergone sterilization must agree to use effective contraceptive measures from the beginning of the study treatment (chemotherapy) until one year after the last cell transfusion.
Exclusion
- The last dose of anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization or traditional Chinese medicine / Chinese herbal medicine with anti-tumor indications) was received within 4 weeks before cell reinfusion;
- The live attenuated vaccine had been inoculated within 4 weeks before cell reinfusion;
- The patients with bone metastasis in the whole body;
- It is known that any component used in the treatment of this study will produce allergy Response;
- Not recovered from previous operation or treatment-related adverse reactions to \< 2-level CTCAEv5.0;
- Patients with a history of meningeal or central nervous system metastasis, or patients with clear basic diseases of central nervous system and left significant symptoms within 6 months before cell transfusion;
- Patients with poor drug control hypertension (systolic blood pressure \> 160mmhg and / or diastolic blood pressure \> 90mmHg) or with clinical significance Cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (within 6 months prior to signing the master informed consent), myocardial infarction (within 6 months prior to signing the master informed consent), unstable angina pectoris, congestive heart failure with NYHA grade II or above, or serious arrhythmia that cannot be controlled by drugs or has potential impact on research and treatment Results of ECG showed clinically significant abnormality or average QTCF ≥ 450ms;
- Combined with other serious organic or mental diseases;
- Suffering from systemic active infection requiring treatment, including but not limited to active tuberculosis, known HIV positive patients or clinical active hepatitis A, B and C Patients with inflammation, including virus carriers, should be excluded;
- Patients with autoimmune diseases: those with inflammatory bowel disease history and those with autoimmune disease history determined by the researchers as unsuitable for this study, such as systemic lupus erythematosus, vasculitis, and invasive lung disease, should be excluded (except vitiligo subjects);
- Those with cell transfusion within 4 weeks before and during the study should be used (if there is a long-term plan) Use) systemic sterols, hydroxyurea, immunomodulators (e.g., interferon α or γ, GM-CSF, mTOR inhibitors, cyclosporin, thymosin, etc.);
- History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
- Diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure that are not known to be controlled;
- Alcohol and / or drug abusers;
- Pregnant or lactating women;
- Subjects with any coexisting medical conditions or diseases that may affect the development of this study determined by the investigator;
- Subjects without legal capacity / limited capacity of behavior;
- Patients who have received similar gene therapy products within 4 weeks before cell reinfusion and are not suitable for inclusion by evaluation;
- Patients judged by the investigator are difficult to complete all visits or procedures required by the protocol (including the follow-up period), or insufficient compliance to participate in the study, or the patients considered unsuitable by the investigator.
Key Trial Info
Start Date :
March 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04318964
Start Date
March 19 2020
End Date
May 1 2024
Last Update
April 12 2023
Active Locations (1)
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1
Xing Zhang
Guangzhou, Guangdong, China, 510060