Status:
COMPLETED
Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients with Synovial Sarcoma
Lead Sponsor:
Takara Bio Inc.
Conditions:
Synovial Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.
Detailed Description
Following pre-treatment with cyclophosphamide, NY-ESO-1-specific T cell receptor (TCR) gene transduced T lymphocytes are transferred to human leukocyte antigen (HLA)-A\*02:01 or HLA-A\*02:06 positive ...
Eligibility Criteria
Inclusion
- Histologically confirmed synovial sarcoma
- Surgically unresectable tumor
- Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline
- HLA-A\*02:01 or HLA-A\*02:06 positive
- Tumor that express NY-ESO-1 by immunohistochemistry
- ≥ 18 years of age
- Measurable lesions that are evaluable by the RECIST ver1.1
- ECOG Performance Status of 0, 1 or 2
- No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing
- Life expectancy ≥ 16 weeks after consent
- 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
- 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
- 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.
- Active metastatic tumor cell invasion into CNS
- Active multiple cancer
- Positive for HBs antigen or HBV-DNA observed in serum
- Positive for HCV antibody and HCV-RNA observed in serum
- Positive for antibodies against HIV or HTLV-1
- Left Ventricular Ejection Fraction (LVEF) ≤ 50%
- History of serious hypersensitivity reactions to bovine or murine derived substances.
- History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study
- History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study.
- 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.
- 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.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03250325
Start Date
September 20 2017
End Date
March 9 2022
Last Update
November 20 2024
Active Locations (5)
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1
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan, 060-8543
2
Mie University Hospital
Tsu, Mie-ken, Japan, 514-8507
3
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan, 540-0006
4
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045