Trials / Withdrawn
WithdrawnNCT05613348
CD19 CAR T-cell Target Relapsed/Refractory Acute B Cell Leukemia/Lymphoma
Humanized CAR19T2 T Cell in Children With Refractory/Relapsed B-cell Leukemia/Lymphoma
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Zhujiang Hospital · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor-T cell (CAR19T2 T cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/lymphoma.
Detailed description
CD19 CAR-T cells treating B-cell hematological malignancies have achieved unprecedented success. In this study, we investigated new third-generation autologous T cells (CAR19T2 T cells) genetically modified with humanized anti-CD19 construct incorporating CD28 and Toll-like receptor 2 (TLR2) costimulatory domains. CAR19T2 T cells will be modified before the infusion to those which could identify and kill the tumor cells (CD19+ cells). This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor T cell (CAR19T2 T Cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 CAR T-Cell(CAT19T2) | Drug: Fludarabine， Administered intravenously Drug: Cyclophosphamide， Administered intravenously |
Timeline
- Start date
- 2022-12-01
- Primary completion
- 2025-12-01
- Completion
- 2028-12-01
- First posted
- 2022-11-14
- Last updated
- 2024-03-18
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05613348. Inclusion in this directory is not an endorsement.