Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients with Synovial Sarcoma

Takara Bio

Status and phase

Completed

Phase 2

Phase 1

Conditions

Synovial Sarcoma

Treatments

Biological: TBI-1301

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT03250325

1301-03

Details and patient eligibility

About

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.

Full 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 patients with synovial sarcoma expressing NY-ESO-1, which are surgically unresectable and refractory to anthracycline therapy. The primary objective is to evaluate the safety in the phase 1 and the efficacy in the phase 2.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.