RecruitingPhase 1NCT05990465

LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies


Sponsor

Medical College of Wisconsin

Enrollment

12 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.


Eligibility

Min Age: 18 YearsMax Age: 81 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a special immune cell therapy called LV20.19 CAR T-cells with a targeted drug called pirtobrutinib can better treat relapsed or treatment-resistant B-cell lymphoma — a type of blood cancer — compared to either treatment alone. **You may be eligible if...** - You are between 18 and 80 years old - You have relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), such as follicular lymphoma or diffuse large B-cell lymphoma - Your cancer has not responded to or has come back after previous treatments **You may NOT be eligible if...** - You are under 18 or over 80 years old - You do not have a B-cell NHL diagnosis - Your lymphoma has not relapsed or is not considered refractory 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 will be administered at 200 mg/day orally starting at least 14 days prior to apheresis as bridging until the start of lymphodepletion and restarted between day 28-120 for up to one year as maintenance post cell infusion.

DRUGLV20.19 CAR T cells

Subjects will receive a dose of 2.5x10\^6 CAR-T cells/kg as a previously identified safe in a Phase 1 protocol at the Medical College of Wisconsin.


Locations(1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT05990465


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