A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorADC Therapeutics S.A.

About this trial

The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.

Eligibility criteria

Qualifiers

Male or female participants aged 18 years or older

Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen

Measurable disease as defined by the 2014 Lugano Classification

Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN)

Disqualifiers

Previous therapy with loncastuximab tesirine

Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1)

Human immunodeficiency virus (HIV) seropositive

Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load

Trial design

Treatments tested in this trial

  • Loncastuximab Tesirine

Treatment groups

56 Participants
are divided into 3 treatment groups

Sponsors and collaborators