drugset / Trial / NCT06220097
Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies
Phase 2
Active not recruiting
28 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CSPC Pharmaceutical Group Limited · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this open, single-arm practical, phase II, clinical study is to evaluate the efficacy and safety of the mitoxantrone hydrochloride liposome injection-containing regimens in bridging therapies of CD19 CAR-T cells. The main question it aims to answer is: • the efficacy of the mitoxantrone hydrochloride liposome injection-containing combination regimens in bridging therapies of CD19 CAR-T cells. Participants will receive combination bridging regimens including mitoxantrone hydrochloride liposomal injection and CAR-T cell therapy to see if the combination regimens have a positive effect on the efficacy of bridging therapies.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2024-08-01
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19 CAR-T cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Mitoxantrone | Small molecule | — | — |
| Background | Fludarabine | Small molecule | — | — |