Long-term follow-up of TBI-1301

JRCT ID: jRCT1043210160

Registered date:17/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: relapsed or refractory solid tumors
• Date of first enrollment: 24/06/2015
• Target sample size: 2
• Study type: Observational

Outcome(s)

Primary Outcome

1. Detection of replication-competent retrovirus by polymerase chain reaction (PCR)
2. Detection of the appearance of cell clonality by linear amplification-mediated (LAM)-PCR

Secondary Outcome

1. Safety of TBI-1301 and lymphodepletion preconditioning drug (cyclophosphamide) judged by analysis of clinical information
2. Residual infused T cells (TBI-1301) by PCR

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically or cytologically confirmed solid tumors
2) Unresectable and refractory to standard of care such as chemotherapy and radiotherapy
3) HLA-A*02:01 or HLA-A*02:06 positive
4) Confirmed expression of NY-ESO-1 in tumor cells by immunohistochemical staining or quantitive reverse transcription polymerase chain reaction
5) Eastern Cooperative Oncology Group performance status of 0 or 1
6) 20 years of age or older
7) Life expectancy of at least 16 weeks
8) No severe damage to major organs (including bone marrow, heart, lung, liver, and kidney), which requirse to meet the following laboratory values:
(1) white blood cell count at least 2,500/mm3
(2) hemoglobin at least 8.0 g/dL
(3) platelet count at least 75,000/mm3
(4) serum total bilirubin of less than 1.5 times upper limit of normal (ULN)
(5) alanine aminotransferase and aspartate aminotransferase of less than 3.0 times ULN
(6) creatinine of less than 1.5 times ULN
9) Written informed consent

Exclude criteria

(1) Unstable angina, myocardial infarction, or congestive heart failure
(2) Poorly controlled diabetes mellitus or hypertention
(3) Active infection
(4) Obvious interstitial pneumonitis or pulmonary fibrosis by a chest X-ray
(5) Active autoimmune diseases which require steroids or immunosuppressant, except for post-pituitaryitis (caused by previous treatment) adrenal insufficiency which have been treated with hormone replacement therapy
(6) Severe hypersensitivity
(7) Central nervous sysyem involvement of tumor cells
(8) Active synchronous or metachronous cancer, except for carcinoma in situ (intraepithelial cancer) or intramucosal cancer judged to be cured by local treatment, or other cancers for which the patients has been disease-free for 5 years
(9) Hepatitis B virus (HBV) surface antigen or HBV-DNA positive
(10) Antibody against hepatitis C virus (HCV) and HCV-RNA positive
(11) Antibody against human immunodeficiency virus or human T-cell leukemia virus type 1 positive
(12) Ejection fraction of 50% or less
(13) Percutaneous oxygen saturatoion of less than 94%
(14) History of severe allergic reaction to cattle or mouse-derived ingredients
(15) History of severe allergic reaction to any of the drugs used in this clinical trial
(16) Psychiatric diseases or drug addiction judged not to be able to provide informed consent to participate in clinical trials
(17) Pregnant or lactating women, or patients of either sex who were not willing to practice birth controll from the time of consent through 6 months following TBI-1301 infusion

Related Information

• Primary Sponsor: Watanabe Takashi
• Secondary Sponsor: BrightPath Biotherapeutics Co., Ltd.