Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid tumors.
Following pre-treatment with cyclophosphamide alone or in combination with fludarabine, MAGE-A4-specific TCR gene transduced T lymphocytes are transferred to HLA-A\*24:02 positive patients with solid tumors which are 1) unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc), metastatic or recurrent, and 2) MAGE-A4-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
18
TBI-1201(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-1201
Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1201 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: 8 weeks
Appearance of replication competent retrovirus by PCR
Confirm no replication competent retrovirus observed
Time frame: 8 weeks
Appearance of clonality by LAM-PCR
Confirm no clonality is observed
Time frame: 8 weeks
Kinetics of TBI-1201 in blood by realtime-PCR and flow cytometry
Evaluate persistence and expansion of transferred TBI-1201
Time frame: 8 weeks
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