drugset / Trial / NCT05351593

Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma

NCT05351593

Phase 1/2 Recruiting 35 enrolled James Rubenstein Incyte Corporation · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a single arm open-label multicenter phase I/II investigation of combination lenalidomide/Tafasitamab in patients with relapsed central nervous system (CNS) lymphoma. This is the first study to examine a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients as well as the combination of anti-CD19 antibody plus an Immunomodulatory imide drugs (IMiDs) in CNS lymphomas. This study will also test the novel hypothesis that Tafasitamab enhances blood-brain barrier permeability, a potential property that could have broad clinical implications.

Timeline

Start
2022-06-08
Primary completion
2026-12-31
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Tafasitamab Monoclonal antibody 12 mg/kg Intravenous