RecruitingPhase 1Phase 2NCT05351593

Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma

A Phase I/II Study of Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma


Sponsor

James Rubenstein

Enrollment

35 participants

Start Date

Jun 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — tafasitamab (an antibody targeting cancer cells) and lenalidomide (an immune-modulating drug) — for people with lymphoma that has come back in the brain or spinal fluid (called CNS lymphoma). This is a difficult-to-treat condition with limited options. **You may be eligible if...** - You are 18 or older with relapsed DLBCL-type CNS lymphoma (brain, spinal fluid, or eye involvement) - You have received at least one prior treatment - Your organ function meets requirements and your performance status is adequate (ECOG 0–1) - You have an anticipated survival of more than 2 months **You may NOT be eligible if...** - You have received anti-CD19 therapy or CAR-T cell therapy previously - You have HIV - You have had systemic cancer therapy within the past 2 weeks, or antibody therapy within the past 4 weeks - You are known to be allergic to lenalidomide or tafasitamab - You are pregnant or breastfeeding, or unwilling to use effective contraception - You have CNS post-transplant lymphoproliferative disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTafasitamab

Given IV

DRUGLenalidomide

Given Orally


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT05351593


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