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CAR T-cell Therapy

Pirtobrutinib + CAR T-cell Therapy for Mantle Cell Lymphoma

Phase 2

Recruiting

Led By Michael Jain, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Patients with a histologically confirmed diagnosis of mantle cell lymphoma (MCL) will be eligible

Adult males or females who are 18 years of age or older at time of signing informed consent

Must not have

Patients with active CNS involvement of Mantle Cell Lymphoma

Inability of the participant to swallow and retain oral medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with a type of lymphoma that has come back or not responded to previous treatments. The treatment involves a type of therapy called CD19 CAR T-cell therapy

Who is the study for?

This trial is for people with a type of lymphoma called relapsed/refractory mantle cell lymphoma (R/R MCL) who qualify for standard CD19 CAR T-cell therapy. Specific eligibility details are not provided, but typically participants need to meet certain health standards and have no conflicting conditions.

What is being tested?

The study is testing two treatments: Brexucabtagene Autoleucel, a form of CAR T-cell therapy, and Pirtobrutinib, a medication. It's an open-label trial where patients are randomly assigned to receive one of these interventions.

What are the potential side effects?

While specific side effects aren't listed here, CAR T-cell therapies like Brexucabtagene Autoleucel can cause immune system reactions and Pirtobrutinib may lead to bleeding issues or infections.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with mantle cell lymphoma.

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I am 18 years or older and can give informed consent.

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I am eligible for a specific immune therapy (CAR T-cell) for my mantle cell lymphoma.

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I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

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

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My Mantle Cell Lymphoma has spread to my brain or spinal cord.

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I cannot swallow or keep down oral medication.

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

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I have previously undergone CAR T-cell therapy.

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I do not have serious or unmanaged heart conditions.

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I have an active infection that is not being treated.

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I am HIV positive.

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I currently have an active CMV infection.

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I am currently taking long-term steroids or immunosuppressants.

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I have not had major surgery in the last 4 weeks.

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I stopped taking pirtobrutinib because my disease got worse or due to side effects.

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I need blood thinners like warfarin for my condition.

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I have not had a stroke or brain bleed in the last 6 months.

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I have an active autoimmune disease affecting my brain or spinal cord.

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I have a history of a genetic bleeding disorder.

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I have an active autoimmune condition affecting my blood cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free survival (PFS) - Comparison between arm A and arm B

Progression-free survival (PFS) - Historical comparison

Secondary study objectives

Overall Response Rate (ORR)

Overall survival (OS)

Severe CRS

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment2 Interventions

Participants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants on Arm B (n=30) will discontinue pirtobrutinib after day -7 and will not receive concurrent pirtobrutinib ("con-none") between day -6 and 1-year post-CD19 CAR T-cell therapy.

Group II: Arm AExperimental Treatment2 Interventions

Participants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants randomized to Arm A (n=30) will continue to receive concurrent pirtobrutinib ("con-pirto"), starting at day -6 and continued until 1-year post-CD19 CAR T-cell therapy with brexucel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pirtobrutinib

2020

Completed Phase 1

~240

0 / 20Eligibility criteria met