drugset / Trial / NCT05806099
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)
Timeline
- Start
- 2023-06-28
- Primary completion
- 2025-11
- Completion
- 2026-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MBS303 | Protein / enzyme biologic | 0.05 mg | Intravenous |
| Subject | MBS303 | Protein / enzyme biologic | 0.15 mg | Intravenous |
| Subject | MBS303 | Protein / enzyme biologic | 0.45 mg | Intravenous |
| Subject | MBS303 | Protein / enzyme biologic | 1.5 mg | Intravenous |
| Subject | MBS303 | Protein / enzyme biologic | 6 mg | Intravenous |
| Subject | MBS303 | Protein / enzyme biologic | 60 mg | Intravenous |