Trials / Unknown
UnknownNCT03275493
CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia
Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
- Sex
- All
- Age
- 6 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.
Detailed description
Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells； 2. CD19 CAR-T cells with CRS suppression technology.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 CAR-T cells | Express a Second Generation 4-1BB: CD19 CAR-T cells |
| BIOLOGICAL | CD19 CAR-T cells with CRS suppression technology | Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology |
Timeline
- Start date
- 2017-07-01
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2017-09-07
- Last updated
- 2024-05-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03275493. Inclusion in this directory is not an endorsement.