drugset / Trial / NCT02454270
A Dose Escalation Study of Duvortuxizumab in Participants With Relapsed or Refractory B-cell Malignancies
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to participants with relapsed or refractory B-cell malignancies \[diffuse-large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL)\].
Timeline
- Start
- 2015-06-15
- Primary completion
- 2018-07-26
- Completion
- 2018-07-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duvortuxizumab | Protein / enzyme biologic | 0.5 ng | Intravenous |
| Subject | Duvortuxizumab | Protein / enzyme biologic | 50 ng | Intravenous |