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

• Status: Terminated
• Trial end date: 2018-07-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.

Criteria

Inclusion Criteria:

• Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies

• Measurable disease

• Eastern Cooperative Oncology Group status of 0 or 1

• Adequate baseline renal and hepatic function

Exclusion Criteria:

• Prior treatment with CD19 directed agents unless CD19 expression is confirmed after completion of CD19-directed treatment

• Known HIV, active hepatitis B or active hepatitis C infection

• Prior allogeneic stem cell transplant

• Inadequate lung function

• Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment