Phase Ib Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumours
The target populations for this phase I study with TBI-1301 are patients with advanced solid
tumours. Patients' tumours will be required to express NY-ESO-1, which include but is not
limited to ovarian cancer, synovial sarcoma, esophageal cancer and malignant melanoma.
Patients must be positive for HLA-A*02:01 or HLA-A*02:06 and the patient's tumour tissue must
be positive for NY-ESO-1 antigen expression. The study will take the subject's T cells,
which are a natural type of immune cell in the blood, and send them to a laboratory to be
modified. The changed T cells used in this study will be the subject's own T cells that have
been genetically changed with the aim of attacking and destroying cancer cells.
The manufacturing of T cells takes about 1 month to complete. The T cells will be given back
to the subject through an intravenous infusion. The purpose of this study is to test the
safety of genetically changed T cells and find out what effects, if any, they have in
subjects with advanced solid tumours.
The purpose of this study is to evaluate the safety profile of TBI-1301, to determine the
recommended phase 2 (RP2D) dose of TBI-1301 when administered following cyclophosphamide
pre-treatment and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.
View this trial on ClinicalTrials.gov
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