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

NCT06043674 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-01-07

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Glofitamab

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

DRUG

Obinutuzumab

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

DRUG

Polatuzumab Vedotin

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

DRUG

Atezolizumab

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

DRUG

Tocilizumab

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

DRUG

Pirtobrutinib

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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Loxo Oncology, Inc.

    collaborator INDUSTRY

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Christine Ryan

    lead OTHER

Principal Investigators

  • Christine Ryan, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2028-01-15
Completion
2033-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043674 on ClinicalTrials.gov