Trials / Active Not Recruiting
Active Not RecruitingNCT03155191
Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia
A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Takara Bio Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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/day×2 days) on Day -3 and Day -2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2035-03-31
- Completion
- 2035-03-31
- First posted
- 2017-05-16
- Last updated
- 2024-11-20
Locations
11 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03155191. Inclusion in this directory is not an endorsement.