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)

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 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 criteria

Qualifiers

Male or female participant 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) B-NHL (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens in Part 1; and at least one systemic treatment regimen in Part 2

DLBCL, not otherwise specified (NOS)

Germinal Center B-cell type

Disqualifiers

Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human ADA to a CD19 antibody

Previous therapy with loncastuximab tesirine

Previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab (applied to relevant arm and/or cohort of the specific drug administered)

Participants who received previous treatment of polatuzumab vedotin containing regimen will be excluded from Arm C

Trial design

Treatments tested in this trial

  • Loncastuximab Tesirine
  • Polatuzumab Vedotin
  • Glofitamab
  • Mosunetuzumab
  • Obinutuzumab

Treatment groups

200 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators