Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
The target populations for this phase I study with TBI-1301 are patients with advanced solid
tumors. Patients' tumors will be required to express NY-ESO-1, which include but is not
limited to ovarian cancer, synovial sarcoma, esophageal cancer, lung cancer, bladder cancer,
liver cancer, and malignant melanoma. Patients must be positive for HLA-A*02:01 or
HLA-A*02:06 and the patient's tumor 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 tumors.
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 and
fludarabine pre-treatment, to evaluate the safety of repeat dosing of TBI-1301, to assess the
presence/absence of RCR appearance after TBI-1301 infusion, to assess the presence or absence
of clonality by LAM-PCR, and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.