Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors.
Following pre-treatment with cyclophosphamide alone or in combination with fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to HLA-A\*02:01 or HLA-A\*02:06 positive patients with solid tumors which are 1) unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc), and 2) NY-ESO-1-expressing. The primary objective is to evaluate the safety and in vivo kinetics, and the secondary is to evaluate clinical effect.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
TBI-1301(5\*10\^8 or 5\*10\^9) is administered.
Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1301 in combination with cyclophosphamide.
Mie University Hospital
Tsu, Mie-ken, Japan
Incidence and grade of adverse events (CTCAE)
• Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
Time frame: 4 weeks
Appearance of replication competent retrovirus by PCR
Confirm no replication competent retrovirus observed.
Time frame: 4 weeks
Appearance of clonality by LAM-PCR
Confirm no clonality is observed.
Time frame: 4 weeks
Kinetics of TBI-1301 in blood by realtime-PCR
Evaluate persistence and expansion of transferred TBI-1301.
Time frame: 8 weeks
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