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ACTIVE NOT RECRUITING
NCT03155191
PHASE1/PHASE2

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

Sponsor: Takara Bio Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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