RecruitingPhase 1NCT04970901

A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Sponsor

ADC Therapeutics S.A.

Enrollment

200 participants

Start Date

Jun 17, 2022

Study Type

INTERVENTIONAL

Summary

The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called LOTIS-7) is testing the drug loncastuximab tesirine — an antibody that delivers chemotherapy directly into lymphoma cells — in combination with other cancer agents, for people with B-cell non-Hodgkin lymphoma (a blood cancer) that has returned or stopped responding to prior treatments. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of relapsed or refractory B-cell non-Hodgkin lymphoma (including DLBCL, high-grade B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma depending on the study arm) - You have failed at least one prior treatment (for some arms, at least two prior treatments are required) - You have no other approved therapy available or you cannot tolerate it **You may NOT be eligible if...** - Your lymphoma has not returned or is still responding to current treatment - You have not received the minimum required number of prior therapies for your specific arm - You have serious health problems that make participation unsafe - 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

DRUGLoncastuximab Tesirine

Intravenous (IV) infusion

DRUGPolatuzumab Vedotin

IV infusion

DRUGGlofitamab

IV infusion

DRUGMosunetuzumab

Subcutaneous (SC) injection

DRUGObinutuzumab

IV infusion

Locations(42)

University of California San Francisco - Fresno Center for Medical Education and Research

Clovis, California, United States

Scripps Health - Prebys Cancer Center

San Diego, California, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Memorial Cancer Institute - Memorial Hospital West

Pembroke Pines, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

The Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Mission Cancer + Blood - Mission Cancer Foundation

Des Moines, Iowa, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Penn Medicine - Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Allegheny Health Network - West Penn Hospital

Pittsburgh, Pennsylvania, United States

Brown University Health - Rhode Island Hospital

Providence, Rhode Island, United States

Hollings Cancer Center

Charleston, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR)

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Emily Couric Clinical Cancer Center

Charlottesville, Virginia, United States

NEXT Virginia (Virginia Cancer Specialists)

Fairfax, Virginia, United States

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Universitair Ziekenhuis Gent

Ghent, Belgium

Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Yvoir, Belgium

Fakultni Nemocnice Brno

Brno, South Moravian, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Fakultní Nemocnice Královské Vinohrady

Prague, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

Bergamo, Italy

Centro di Ricerche Cliniche - IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Italy

Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

Brescia, Italy

Istituto Europeo di Oncologia

Milan, Italy

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Complejo Asistencial Universitario de Salamanca - Hospital Clínico

Salamanca, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04970901