NCT02702141

A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma

A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.

Detailed description

SGN-CD19B will be given to patients at increasing doses every 28 days (or on an alternative dosing schedule of every 42 days). Individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the Safety Monitoring Committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.

Conditions

• Non-Hodgkin Lymphoma
• DLBCL
• Diffuse Large B-cell Lymphoma
• Grade 3 Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	SGN-CD19B	Given intravenously Day 1 of 28-day or 42-day cycles

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-07-10
• Completion: 2018-07-10
• First posted: 2016-03-08
• Last updated: 2018-08-13

Locations

16 sites across 1 country: United States