Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Eligibility
Primary outcome measure(s)
- Phase-I portion: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 — One year
Adverse event (frequency, seriousness, duration, causality, severity, classification), mortality, severe adverse event, discontinuation due to adverse event. - Phase-II portion: Anti-tumor effect (CR+CRi rate) — 56 days
Complete Remission (CR)+Complete Remission with Incomplete Blood Count Recovery (CRi) , as determined by assessments of peripheral blood and bone marrow.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Akita University Hospital | Akita | Akita | |
| University Of Fukui Hospital | Yoshida | Fukui | |
| Kyushu University Hospital | Higashiku | Fukuoka | |
| Hokkaido University Hospital | Sapporo | Hokkaido | |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | |
| Mie University Hospital | Tsu | Mie-ken | |
| Tohoku University Hospital | Sendai | Miyagi | |
| Okayama University Hospital | Okayama | Okayama-ken | |
| Jichi Medical University hospital | Shimotsuke-shi | Tochigi | |
| Cancer Institute Hospital Of JFCR | Kōto | Tokyo | |
| The Institute of Medical Science, The University of Tokyo | Minato-ku | Tokyo |
More Takara Bio Inc. trials in Japan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03155191 on ClinicalTrials.gov ↗ ← All trials in Japan