drugset / Trial / NCT06911710
The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors
Phase 1/2
Recruiting
90 enrolled
Tianjin Medical University General Hospital
Hebei Taihe Chunyu Biotechnology Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological neoplasms in subjects.
Timeline
- Start
- 2024-11-09
- Primary completion
- 2026-02-28
- Completion
- 2027-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAR19 | Cell therapy | 1e+06 cells/kg | Other |
| Subject | CAR19 | Cell therapy | 1.5e+06 cells/kg | Other |
| Subject | CAR19 | Cell therapy | 2e+06 cells/kg | Other |
| Subject | CAR19 | Cell therapy | 2.5e+06 cells/kg | Other |
| Subject | CAR19 | Cell therapy | 3e+06 cells/kg | Other |
| Subject | CAR2019 | Cell therapy | 1e+06 cells/kg | Other |
| Subject | CAR2019 | Cell therapy | 1.5e+06 cells/kg | Other |
| Subject | CAR2019 | Cell therapy | 2e+06 cells/kg | Other |
| Subject | CAR2019 | Cell therapy | 2.5e+06 cells/kg | Other |
| Subject | CAR2019 | Cell therapy | 3e+06 cells/kg | Other |
| Subject | CAR2219 | Cell therapy | 1e+06 cells/kg | Other |
| Subject | CAR2219 | Cell therapy | 1.5e+06 cells/kg | Other |
| Subject | CAR2219 | Cell therapy | 2e+06 cells/kg | Other |
| Subject | CAR2219 | Cell therapy | 2.5e+06 cells/kg | Other |
| Subject | CAR2219 | Cell therapy | 3e+06 cells/kg | Other |