Progressive or metastatic soft tissue sarcoma
Conditions
Interventions
Intervention type:GENE TRANSFER,VACCINE
Name of intervention:TBI-1301 and CHP:NE1
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAVENOUS D
CpG oligoDNA (K3)), 0.8 mg [Cohort option 1](ellipsis)[Cohort option 2](ellipsis) (P2 part) Recommended dose from P1 part
Dosing frequency / Frequency of use:OTHER, SPECIFY
TBI-1301, twice (Day 1, Day
Sponsors
Mikiya Ishihara
Akihiko Matsumine, Yasuhiro Nagata
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (P1 part) Safety (P2 part) Tumor response | — |
Secondary
| Measure | Time frame |
|---|---|
| (P1 part) 1) Tumor response 2) Progression free survival (PFS) 3) Overall survival (OS) 4) Immune response (P2 part) 1) Progression free survival (PFS) 2) Overall survival (OS) 3) Safety 4) Immune response | — |
Countries
Japan
Contacts
Public ContactTatsushi Goto
Secretariat of clinical trial coordinating committee
Outcome results
None listed