Last updated on February 2019

Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia

Brief description of study

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.

Detailed Study Description

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/day2 days) on Day -3 and Day -2.

Clinical Study Identifier: NCT03155191

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Mie University Hospital

Tsu-shi, Japan
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Recruitment Status: Open

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