Study Summary
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.
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TBI-1501BIOLOGICAL
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.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Akita University Hospital | Akita | Akita | Japan |
| University Of Fukui Hospital | Yoshida | Fukui | Japan |
| Kyushu University Hospital | Higashiku | Fukuoka | Japan |
| 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 |
| The Institute of Medical Science, The University of Tokyo | Minato-ku | Tokyo | Japan |