Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
NCT05351593 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-02-03
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.
Conditions
- CNS Lymphoma
- Primary Central Nervous System Lymphoma
- Secondary Central Nervous System Lymphoma
Interventions
- DRUG
-
Tafasitamab
Given IV
- DRUG
-
Given Orally
Sponsors & Collaborators
- collaborator INDUSTRY
-
James Rubenstein
lead OTHER
Principal Investigators
-
James Rubenstein, MD, PhD · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-08
- Primary Completion
- 2025-09-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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