Synovial Sarcomas
Conditions
Keywords
adoptive cell transfer, NY-ESO-1, T cell receptor, ex vivo gene therapy, synovial sarcoma
Brief summary
The purpose of this study is to verify the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide/fludarabine pre-treatment.
Interventions
BIOLOGICALTBI-1301
Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment.
DRUGCyclophosphamide
Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
DRUGFludarabine
Fludarabine (30mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
Sponsors
Takara Bio Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age 2. Histologically confirmed synovial sarcoma 3. Surgically unresectable tumor 4. Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline 5. HLA-A\*02:01 or HLA-A\*02:06 positive 6. Tumor that express NY-ESO-1 by immunohistochemistry 7. Measurable lesions that are 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/μL \< WBC ≤ULN; Hemoglobin ≥ 8.0g/dL; Platelets ≥ 75,000/μL 12. Patients must be able to understand the study contents and to give a written consent at his/her free will.
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. History of serious hypersensitivity reactions to bovine or murine derived substances. 8. History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study 9. History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study. 10. History of treatment with cell therapy or gene therapy 11. Alcohol or drug dependence that may interfere with study participation 12. 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. 13. 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 | Description |
|---|---|---|
| Objective response rate | 52 weeks | Evaluate response rate by measuring response using RECIST v1.1 |
Countries
Japan
Outcome results
None listed