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Monoclonal Antibodies

Glofitamab + Pirtobrutinib for Mantle Cell Lymphoma

Phase 2

Recruiting

Led By C. Babis Andreadis, MD

Research Sponsored by C. Babis Andreadis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of previously treated MCL meeting specific criteria

Agreement for contraceptive measures for men

Must not have

Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist

Current or history of CNS disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of a combination of glofitamab and pirtobrutinib in treating patients with mantle cell lymphoma that has come back or has not responded to

Who is the study for?

This trial is for individuals with mantle cell lymphoma that has returned or hasn't responded to treatment. Participants should have tried at least one prior therapy and be suitable for bone marrow biopsy, tumor imaging, and biospecimen collection.

What is being tested?

The trial tests the combination of glofitamab (a monoclonal antibody) with pirtobrutinib (a kinase inhibitor) against mantle cell lymphoma. It also uses obinutuzumab potentially to reduce immune-related side effects.

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, and potential interference with organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated for mantle cell lymphoma before.

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I agree to use birth control methods.

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My side effects from previous cancer treatments have mostly gone away.

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I am 18 years old or older.

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I can do most activities by myself without help.

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I had hepatitis C but have been successfully treated and cured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on blood thinners like warfarin.

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I have or had a brain or spinal cord disease.

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I had severe bleeding or heart rhythm problems with a previous BTK inhibitor treatment.

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I stopped taking a BTK inhibitor because my disease got worse or came back.

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My cancer has spread to my brain or spinal cord.

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I have another cancer type but it's in remission and I'm expected to live more than 2 years.

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I haven't had certain medical treatments or procedures recently.

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I have not had major surgery in the last 30 days.

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I have a significant history of heart disease.

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I have a serious lung condition.

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I have been diagnosed with progressive multifocal leukoencephalopathy.

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I currently have an active infection or a previously inactive infection that has become active again.

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I have or might have had a condition where my immune system attacks my body.

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I have a history of unusual bleeding.

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I have a condition that affects how my stomach and intestines absorb food.

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I am currently on medication that strongly affects liver enzyme activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with high grade, treatment-emergent adverse events (AEs)

Proportion of participants with Complete Response (CR)

Secondary study objectives

Duration of response (DOR)

Median Overall Survival (OS)

Median Progression-free survival (PFS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (obinutuzumab, glofitamab, pirtobrutinib)Experimental Treatment7 Interventions

Participants receive obinutuzumab IV on days 1 and 2 of cycle 1 for a total of 2 doses. Participants receive glofitamab IV on days 8 and 15 of cycle 1 and day 1 of remaining cycles. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Participants receive pirtobrutinib PO once a day (QD) on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Participants also undergo FDG-PET/CT at screening, after every 4 cycles through cycle 13 and then after every 6 cycles. Participants will undergo a bone marrow biopsy and aspiration at cycle 13 and blood sample collection throughout study and a tissue biopsy at relapse or progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glofitamab

2021

Completed Phase 1

~60

Pirtobrutinib

2020

Completed Phase 1

~240