Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR) (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.
Enroll patients after confirming eligibility. Following enrollment, peripheral blood mononuclear cells and blood plasma will be obtained from each subject by apheresis to start the manufacturing of TBI-1501. Before TBI-1501 administration, it is necessary to pass the quality tests. Subject will be hospitalized from Day -3 to Day 28, and administered Cyclophosphamide (1,000 mg/m2/day×2 days) on Day -3 and Day -2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Phase-I portion: Cyclophosphamide is administered for conditioning medication of TBI1501, that is CD19-CAR-T cells, (cohort -1: 3×10\^5 cells/kg, cohort 1: 1×10\^6 cells/kg, cohort 2: 3×10\^6 cells/kg). Phase-II portion: Recommended dose of Phase-II part will be administered. Cyclophosphamide will be administered as conditioning. The end of study will be Week 52 after administration of TBI-1501.
Akita University Hospital
Akita, Akita, Japan
University Of Fukui Hospital
Yoshida, Fukui, Japan
Kyushu University Hospital
Higashiku, Fukuoka, Japan
Phase-I portion: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse event (frequency, seriousness, duration, causality, severity, classification), mortality, severe adverse event, discontinuation due to adverse event.
Time frame: One year
Phase-II portion: Anti-tumor effect (CR+CRi rate)
Complete Remission (CR)+Complete Remission with Incomplete Blood Count Recovery (CRi) , as determined by assessments of peripheral blood and bone marrow.
Time frame: 56 days
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Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Jichi Medical University hospital
Shimotsuke-shi, Tochigi, Japan
Cancer Institute Hospital Of JFCR
Kōto, Tokyo, Japan
...and 1 more locations