RecruitingPhase 2NCT06043674

Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation

A Phase 2 Study of Glofitamab as Monotherapy or in Combination With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation


Sponsor

Christine Ryan

Enrollment

70 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This research is being done to evaluate Glofitamab by itself or in combination with Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab as possible treatments for Chronic Lymphocytic Leukemia (CLL) that has transformed into Richter's Transformation (RT). The names of the study drugs involved in this research study are: * Glofitamab (a T-cell bispecific humanized monoclonal antibody) * Obinutuzumab (a humanized glycoengineered type II anti-CD20 monoclonal antibody) * Polatuzumab vedotin (an antibody-drug conjugate) * Pirtobrutinib (a selective inhibitor of BTK) * Atezolizumab (a humanized immunoglobulin monoclonal antibody) * Tocilizumab (a recombinant, humanized, anti-human monoclonal antibody)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether glofitamab — a drug that recruits your immune system to attack lymphoma cells — works as a single drug or combined with another cancer drug (polatuzumab vedotin) for people with a rare and aggressive type of lymphoma called transformed follicular lymphoma. **You may be eligible if...** - You are 18 or older - You have been diagnosed with transformed follicular lymphoma - Your lymphoma has relapsed or is no longer responding to treatment - You are well enough to carry out daily activities (good performance status) **You may NOT be eligible if...** - You have active serious infections or uncontrolled other cancers - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGGlofitamab

"2:1" T-cell bispecific humanized monoclonal antibody, administered via intravenous infusion per protocol.

DRUGObinutuzumab

Humanized glycoengineered type II anti-CD20 monoclonal antibody, administered via intravenous infusion per protocol.

DRUGPolatuzumab Vedotin

Antibody-drug conjugate, administered via intravenous infusion per protocol.

DRUGAtezolizumab

Humanized immunoglobulin monoclonal antibody, administered via intravenous infusion per protocol.

DRUGTocilizumab

For the treatment of Cytokine Release Syndrome. Recombinant, humanized, anti-human monoclonal antibody, administered via intravenous infusion per protocol.

DRUGPirtobrutinib

Selective inhibitor of BTK, 50 mg or 100 mg tablet, via oral administration per protocol.


Locations(5)

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06043674


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