Drug intelligence / Profile preview

rituximab + cladribine

Development stage
Unknown
Lead developer
Uppsala University
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

Rituximab + cladribine is a sequential combination therapy being investigated by Uppsala University for the treatment of relapsing-remitting multiple sclerosis (RRMS). The regimen, evaluated in the Phase 2 HiHat trial, involves the initial administration of rituximab, a monoclonal antibody that targets CD20-positive B cells, followed by cladribine, a purine nucleoside analog that selectively depletes both B and T lymphocytes. This sequential approach aims to achieve deep and sustained immune reconstitution to prevent disease activity in MS patients. The treatment protocol typically consists of two cycles of rituximab followed by two cycles of cladribine, spaced one month apart, to maximize efficacy while maintaining an acceptable safety profile.

Other names
Sequential rituximab and cladribineHiHat regimen
02

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