Multi-center Phase I/II Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes following chemotherapy pre-treatment in Patients with Synovial Sarcoma - Phase I/II Study of TBI-1301 in Patients with Synovial Sarcoma

Takara Bio Inc.0 个研究点目标入组 8 人开始时间: 2017年10月16日最近更新: 2023年11月20日

适应症

试验速览

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•1) Patients with the following conditions 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) Active metastatic tumor cell invasion into CNS 3) Active multiple cancer 4) Positive for HBs antigen or HBV-DNA observed in serum 5) Positive for HCV antibody and HCV-RNA observed in serum 6) Positive for antibodies against HIV or HTLV-1 7) Left Ventricular Ejection Fraction (LVEF) =< 50% 8) History of serious hypersensitivity reactions to bovine or murine derived substances. 9) History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study 10) History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study. 11) Pregnant females, lactating females (except when they cease and do not resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to 6 months after infusion of the investigational drug. 12) Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.

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