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 1

• Conditions: Synovial sarcoma

• Registration Number: JPRN-UMIN000029573
• Lead Sponsor: Takara Bio Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-16
• Last Update Posted: 20 November 2023
• Study Completion: 2034-01-31

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[Phase I portion] Adverse event, mortality, severe adverse event, discontinuation due to adverse event, laboratory test values Appearance of clonality by LAM-PCR Blood kinetics of TBI-1301 by realtime-PCR [Phase II portion] Overall response rate

Secondary Outcome Measures

Name	Time	Method
[Phase I portion] Objective response rate Progression free rate at week 12 Progression free survival Overall survival [Phase II portion] Progression free rate Progression free survival Overall survival Adverse event, mortality, severe adverse event, discontinuation due to adverse event, laboratory test values Appearance of RCR Appearance of clonality (LAM-PCR) Blood kinetics of TBI-1301