drugset / Trial / NCT05705570
Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
Timeline
- Start
- 2023-02-07
- Primary completion
- 2028-05-01
- Completion
- 2028-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chimeric antigen receptor T cells | Cell therapy | 100000 cells/kg | — |
| Subject | Chimeric antigen receptor T cells | Cell therapy | 500000 cells/kg | — |
| Subject | Chimeric antigen receptor T cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Chimeric antigen receptor T cells | Cell therapy | 2e+06 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |