drugset / Trial / NCT03191773
A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
Phase 1/2
Unknown
100 enrolled
Second Affiliated Hospital of Guangzhou Medical University
Dongguan People's Hospital · collabFirst People's Hospital of Foshan · collabGuangzhou First People's Hospital · collabShenzhen Institute for Innovation and Translational Medicine · collabThe First Affiliated Hospital of Guangdong Pharmaceutical University · collab
NaSingle-groupOpen-labelTreatment
Summary
Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.
Timeline
- Start
- 2017-06-30
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anti-CD19-CAR transduced T cells | Cell therapy | — | Intravenous |
| Background | Drugs and anti-CD19 CAR transduced T cells | Unknown | 300 mg/m2 | Intravenous |
| Background | Drugs and anti-CD19 CAR transduced T cells | Unknown | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |