RecruitingPhase 2NCT06553872

Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL

A Phase 2, Open-Label, Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in Patients With Relapsed or Refractory Mantle Cell Lymphoma


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

60 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 trial is testing whether giving pirtobrutinib (a BTK inhibitor pill) before and after a CAR T-cell therapy called brexucabtagene autoleucel (Tecartus) can improve outcomes in adults with relapsed or refractory mantle cell lymphoma (MCL) — a type of non-Hodgkin lymphoma that often returns after treatment. **You may be eligible if...** - You are 18 or older with confirmed mantle cell lymphoma that has returned or stopped responding to prior treatment - You are eligible to receive CAR T-cell therapy (brexucabtagene autoleucel) - You have an acceptable performance status (ECOG 0-2) - Your heart, blood, and organ function meet minimum standards **You may NOT be eligible if...** - You have previously received CAR T-cell therapy or been on pirtobrutinib for more than 2 months - You have HIV, active hepatitis B or C, or active CMV infection - You have significant heart disease or uncontrolled irregular heartbeat - You are pregnant or breastfeeding 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

DRUGPirtobrutinib

Pirtobrutinib is a non-covalent BTKi that has preserved activity in the presence of mutations that drive BTKi resistance.

DRUGBrexucabtagene Autoleucel

Brexucabtagene autoleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy (brexu-cel).


Locations(3)

Stanford Cancer Center

Stanford, California, United States

Univ of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT06553872


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