Solid Tumors
Conditions
Sponsors
Mie University, Aichi Medical University, Keio University, National Cancer Center Hospital East, National Cancer Center Hospital, National Hospital Organization Nagoya Medical Center
TAKARA BIO INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed solid tumors 2) Solid tumor, which is unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc.) 3) HLA-A*02:01 or HLA-A*02:06 positive 4) NY-ESO-1-expression by immunohistochemistry or PCR 5) ECOG Performance Status, 0 or 1 6) Age >=20 years on consent 7) No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer. 8) Life expectancy >= 16 weeks after consent 9) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria: WBC >= 2,500/mm^3 Hemoglobin >= 8.0g/dL Platelets >= 75,000/mm^3 T. billirubin < 1.5 x ULN AST(GOT), ALT(GPT) < 3.0 x ULN Creatinine < 1.5 x ULN 10) Ability to understand the study contents and to give a written consent at his/her free will.
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) Tumor cell invasion into CNS 4) Active multiple cancer 5) Positive for HBs antigen or HBV-DNA observed in serum, or 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) Percutaneous Oxygen saturation: < 94% 9) History of serious hypersensitivity reactions to bovine or murine derived substances 10) History of hypersensitivity reaction to drugs used in this study 11) Psycological disorder or drug dependency which may have impact on the consent. 12) 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 after the consent during the study 13) Clinically significant systemic illness that in the judgment of the PI or subinvestigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety 1)Incidence and grade of adverse events (CTCAE) 2)Appearance of replication competent retrovirus 3)Appearance of clonality 4)Kinetics of TBI-1301 in blood by realtime-PCR CTCAE v4 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Tumor Response RECIST v1.1 | — |
Countries
Japan
Outcome results
None listed