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Recruiting Phase 1 NCT04970901

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)

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Trial Parameters

Condition B-Cell Non-Hodgkin Lymphoma
Sponsor ADC Therapeutics S.A.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-06-17
Completion 2026-10-30
Interventions
Loncastuximab TesirinePolatuzumab VedotinGlofitamab

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Brief 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 Criteria

Inclusion Criteria: * 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 * LBCL: Part 2 Arm E enrollment focused on LBCL only * DLBCL, not otherwise specified (NOS) * Germinal Center B-cell type * Activated B-cell type * Transformed FL (note: patients with transformed FL must have received at least one line of systemic therapy post-transformation to be eligible) * HGBCL, with MYC and BCL2 and/or BCL6 rearrangements * HGBCL, NOS * FL Grade 3b * Arm F and Part 1 Arm E: * All LBCL histologies listed above * FL (Grade 1-3a) * MZL * For Arm C only: * All histologies listed above * DLBCL (including transformed dise

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