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Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

NCT06252675 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Obinutuzumab

Given intravenously (IV)

BIOLOGICAL

Glofitamab

Given IV

DRUG

Pirtobrutinib

Given Orally (PO)

PROCEDURE

Tumor Imaging

Undergo regular care imaging/scans

PROCEDURE

Biospecimen Collection

Blood and tissue samples

DEVICE

ClonoSeq 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.

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration.

Sponsors & Collaborators

Principal Investigators

  • Madhav Seshadri, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06252675 on ClinicalTrials.gov