Synovial sarcoma
Conditions
Interventions
As pretreatment, Cyclophosphamide (750 mg/m2) is administered intravenously once a day on day -3 and -2 for 2 days. Split dose of TBI-1301 (5 x 10^9 cells [+-30%]) is administered intravenously on day
Sponsors
Takara Bio Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed synovial sarcoma 2) Surgically unresectable tumor 3) Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracyclin 4) HLA-A*02:01 or HLA-A*02:06 positive 5) Tumor that express NY-ESO-1 by immunohistochemistry 6) >= 18 years of age 7) Measurable lesions that are expected to be evaluable by the RECIST ver1.1 8) ECOG Performance Status of 0, 1 or 2 9) No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing 10) Life expectancy >= 16 weeks after consent 11) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria; - Total bilirubin < 1.5 x upper limit of normal (ULN) - AST(GOT), ALT(GPT) < 3.0 x ULN - Creatinine < 1.5 x ULN - 2,500/microL < WBC =< ULN - Hemoglobin >= 8.0g/dL - Platelets >= 75,000/microL 12) Patients must be able to understand the study contents and to give a written consent at his/her free will. Additionally, if patients are below 20 years of age, proxies must be able to give a written consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [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
| Measure | Time frame |
|---|---|
| [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 | — |
Countries
Japan
Outcome results
None listed