RecruitingPhase 1Phase 2NCT06029309

Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma

A Phase 1/2 Study of Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma


Sponsor

Alvaro Alencar, MD

Enrollment

27 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study to find the ideal dose for the combination treatment of Zanubrutinib and Tafasitamab in patients with mantle cell lymphoma. Another purpose is to assess how well the combination treatment works in patients with the study disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — zanubrutinib (a BTK inhibitor that blocks a protein cancer cells use to grow) and tafasitamab (an antibody that targets the CD19 protein on cancer cells) — for patients with mantle cell lymphoma (MCL), a type of non-Hodgkin lymphoma. The study has two phases: one for relapsed patients and one for newly diagnosed patients who are not eligible for intensive chemotherapy. **You may be eligible if...** - You are 18 or older with confirmed mantle cell lymphoma - Phase 1: Your MCL has relapsed after 1–3 prior treatments - Phase 2: You have newly diagnosed MCL that your doctor does not think is suitable for aggressive chemotherapy - Your blood counts and organ function meet the minimum requirements **You may NOT be eligible if...** - You have lymphoma that has spread to the brain - You have serious heart problems (including QTc prolongation or recent heart attack) - You are pregnant or breastfeeding - You have active hepatitis B or C infection - You have had a prior bone marrow transplant from a donor 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

DRUGZanubrutinib

Participants will be administered Zanubrutinib orally (PO) via capsules daily during each 28-day cycle at the following dose levels: * Phase 1 Dose Level 1: 320 mg * Phase 1 Dose Level -1: 240 mg * Phase 2: Recommended dose determined in Phase 1.

DRUGTafasitamab

Participants will be administered a 12 mg/kg dose of Tafasitamab intravenously (IV) during each 28-day cycle as follows: * Early Induction - Cycle 1: Days 1, 4, 8, 15, and 22 * Early Induction - Cycles 2 and 3: Days 1, 8, 15 and 22 * Late Induction - Cycles 4 through 12: Days 1 and 15


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06029309


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