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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

March 31, 2035

Study Completion Date

March 31, 2035

Conditions
Lymphoblastic Leukemia, Acute Adult
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."

Trial Locations (11)

010-8543

Akita University Hospital, Akita

910-1193

University Of Fukui Hospital, Yoshida

812-8582

Kyushu University Hospital, Higashiku

060-8648

Hokkaido University Hospital, Sapporo

650-0047

Kobe City Medical Center General Hospital, Kobe

514-8507

Mie University Hospital, Tsu

980-8574

Tohoku University Hospital, Sendai

700-8558

Okayama University Hospital, Okayama

329-0498

Jichi Medical University hospital, Shimotsuke-shi

135-8550

Cancer Institute Hospital Of JFCR, Kōto

108-8639

The Institute of Medical Science, The University of Tokyo, Minato-ku

All Listed Sponsors
lead

Takara Bio Inc.

INDUSTRY

NCT03155191 - Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter