Investigator-initiated multi-institutional clinical trial of combination therapy of vaccination and gene-modified T cell targeting NY-ESO-1-antigen for refractory soft tissue sarcoma - TriCombo study

Mikiya Ishihara0 个研究点目标入组 12 人开始时间: 2018年5月2日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Progressive or metastatic soft tissue sarcoma confirmed histologically or cytologically
•2) Unresectable and refractory to standard therapy
•3) HLA-A*02:01 positive or HLA-A*02:06 positive
•4) Tumor tissue with NY-ESO-1 antigen by immunohistochemistry or RT-PCR
•5) ECOG Performance Status is 0 or 1
•6) Age >=20 years on informed consent. In phase 2 part, age >=12 years and weight >= 35 kg (if < 16 years)
•7) Patients possible to discontinue or interrupt a treatment, such as chemotherapy, and expected sufficient recovery of the blood cell numbers at the time of T lymphocyte collection
•8) No severe damage on major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the prescribed lab value criteria
•9) Ability to understand the study content and to give a written consent at free will.
•If the patient is < 20 years, a written consent by the legally acceptable representative is required
•10) (Only phase 2 part) Patients who have one or more target lesions designated by RECIST Ver. 1.1

•1) The following serious complications are excluded from the study;
•unstable angina, cardiac infarction or heart failure, uncontrolled diabetes or hypertension, active infection, obvious interstitial pneumonia or lung fibrosis by chest X-ray, active autoimmune disease requiring steroids or immunosuppressive therapy
•2) Serious hypersensitivity
•3) Uncontrollable pleural effusion, ascites and cardiac effusion
•4) Tumor cell invasion into CNS
•5) Active multiple cancer
•6) Positive for HBs antigen or HBV-DNA observed in serum, or positive for HCV antibody and HCV-RNA observed in serum
•7) Positive for antibodies against HIV or HTLV-1
•8) History of serious hypersensitivity reactions to bovine or murine derived substances
•9) History of hypersensitivity reaction to drugs used in this study
•10) Psycological disorder or drug dependency which may have impact on the consent
•11) Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent of the study to 6 months after last administration of TBI-1301

发起方

Mikiya Ishihara