RecruitingPhase 2NCT06252675

Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

A Multicenter Phase 2 Study of Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma


Sponsor

University of California, San Francisco

Enrollment

30 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two immunotherapy drugs — glofitamab and pirtobrutinib — in people with mantle cell lymphoma (a type of blood cancer) that has come back or stopped responding to treatment. Each drug works differently to help the immune system fight the cancer, and combining them may be more effective. **You may be eligible if...** - You are 18 or older with mantle cell lymphoma that has relapsed or not responded to at least one prior treatment (including a CD20 antibody and alkylating chemotherapy) - You have at least one measurable tumor on imaging (PET/CT scan) - You are in reasonably good health (ECOG performance status 0–1) - Your expected survival is at least 12 weeks - Tumor tissue from your most recent progression is available **You may NOT be eligible if...** - Your general health is poor - You have received certain prior treatments that overlap with these drugs - You have active serious infections or other conditions that would make treatment unsafe 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

BIOLOGICALObinutuzumab

Given intravenously (IV)

BIOLOGICALGlofitamab

Given IV

DRUGPirtobrutinib

Given Orally (PO)

PROCEDURETumor Imaging

Undergo regular care imaging/scans

PROCEDUREBiospecimen Collection

Blood and tissue samples

DEVICEClonoSeq Assay

ClonoSEQ is an FDA-cleared, Clinical Laboratory Improvement Amendments of 1988 (CLIA)-validated measure used to determine minimal residual disease (MRD). This helps uncover how much, if any, cancer remains in your body during and after treatment.

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspiration.


Locations(3)

University of California, Davis

Davis, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT06252675


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