Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia (TBI-1501)
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|ClinicalTrials.gov Identifier: NCT03155191|
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoblastic Leukemia, Acute Adult||Biological: TBI-1501||Phase 1 Phase 2|
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/day×2 days) on Day -3 and Day -2.
|Study Type :||Interventional|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Peripheral blood will be collected from a subject after obtaining a written informed consent. Peripheral blood mononuclear cells (PBMCs) and plasma are obtained from the blood, and T cells contained in the PBMCs are transduced with anti-CD19 CAR gene by using retroviral vector.
Cyclophosphamide will be administered after obtaining a written informed consent and completing registration.
CD19-CAR-T will be administered in the split dose. Phase 2 recommended dose will be applied for phase 1 portion. The investigator assesses efficacy of CD19-CAR-T in accordance with study-specific criteria, at 8 week after the infusion of CD19-CAR-T (or at the time of termination). The investigator also assesses the safety during the follow-up period. Long-term follow-up study is conducted at frequency of once a year for 15 years after the infusion of CD19-CAR-T in reference to guidelines of FDA.
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Dose Level -1 to 2
0.3 to 3 x 10^6 autologous CD19-CAR-T cells/kg per patient will be administered intravenously after a conditioning chemotherapy with cyclophosphamide.
cohort -1: 3×10^5 cells/kg cohort 1: 1×10^6 cells/kg cohort 2: 3×10^6 cells/kg.
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).
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.
- Phase-I portion: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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) [ Time Frame: 56 days ]Complete Remission (CR)+Complete Remission with Incomplete Blood Count Recovery (CRi) , as determined by assessments of peripheral blood and bone marrow.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155191
|Contact: Takara Bio Inc.||+firstname.lastname@example.org|
|Kyushu University Hospital||Recruiting|
|Higashi-ku, Fukuoka, Japan, 812-8582|
|Hokkaido University Hospital||Recruiting|
|Sapporo-shi, Hokkaido, Japan, 060-8648|
|Mie University Hospital||Recruiting|
|Tsu-shi, Mie, Japan, 514-8507|
|Tohoku University Hospital||Recruiting|
|Sendai, Miyagi, Japan, 980-8574|
|Jichi Medical University hospital||Recruiting|
|Shimotsuke-shi, Tochigi, Japan, 329-0498|
|The Institute of Medical Science, The University of Tokyo||Recruiting|
|Minato-ku, Tokyo, Japan, 108-8639|
|Study Director:||Masanobu Kimura||Takara Bio Inc.|