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Study of Loncastuximab Tesirine in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following CAR-T Therapy Failure
Sponsor: Istituto Clinico Humanitas
Summary
The goal of this clinical trial is to evaluate whether the drug Loncastuximab Tesirine can treat patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) who have not responded to or have had a relapse after CAR-T therapy. The main question it aims to answer is: * Can Loncastuximab Tesirine improve the overall response rate (ORR) in patients who have failed CAR-T therapy? * What are the safety and potential side effects of Loncastuximab Tesirine in this patient group? This is a single-arm clinical trial, meaning all participants will receive the same treatment and there will be no comparison group. Researchers will focus on evaluating the effectiveness of the drug in helping patients achieve a response to treatment, and they will also assess the safety of the treatment. Participants will: * Be treated with Loncastuximab Tesirine through an intravenous (IV) infusion every 3 weeks for up to 8 cycles. * Undergo regular assessments to monitor the response to treatment, including PET-CT scans and blood tests to check for markers of the disease. * Be asked to provide informed consent before beginning the study and agree to follow the study procedures, including having biopsies performed to analyze biomarkers before starting treatment. * Be followed for up to 2 years after completing the treatment to track their progress and response. This study aims to help doctors understand if Loncastuximab Tesirine can offer a new treatment option for patients who have not responded to CAR-T therapy and have limited options for further treatment. The trial will also provide more information on how to manage the safety of this treatment for these patients.
Official title: Use of LOncastuximab Tesirine in Patients With RElapsed/Refractory Diffuse LargeB-Cell LYmphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL) Who Have Progressive Disease After CAR T-cell Treatment
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-06-16
Completion Date
2027-06
Last Updated
2025-04-09
Healthy Volunteers
No
Conditions
Interventions
Loncastuximab Tesirine (Anti-CD19 Antibody-Drug Conjugate)
Loncastuximab Tesirine is an antibody-drug conjugate specifically targeting CD19, a protein found on the surface of B-cells. It is designed to deliver a cytotoxic pyrrolobenzodiazepine dimer directly to CD19-expressing malignant B-cells. Unlike traditional chemotherapies, Loncastuximab Tesirine combines the precision of an anti-CD19 monoclonal antibody with a potent chemotherapy agent, offering targeted therapy for relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma (HGBCL) after failure of CAR-T therapy. It is administered intravenously every 3 weeks, with an initial higher dose of 150 μg/kg followed by a reduced dose of 75 μg/kg for up to 8 cycles, distinguishing it from other treatments by its specific targeting mechanism and dosage regimen tailored to this patient population.
Locations (7)
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, ALESSANDRIA, Italy
Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, Italy
Azienda Sanitaria Ospedaliera Santa Croce e Carle di Cuneo
Cuneo, Cuneo, Italy
Ospedale San Raffaele
Milan, MILANO, Italy
Istituto Nazionale dei Tumori
Milan, MILANO, Italy
Irccs Istituto Clinico Humanitas
Rozzano, MILANO, Italy
AOU Policlinico Umberto I
Roma, RO, Italy