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Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor: Takara Bio Inc.
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.
Official title: A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2017-06-01
Completion Date
2035-03-31
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
TBI-1501
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.
Locations (11)
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