A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
Stopped early · Phase 1
Conditions studied: Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B-cell Lymphoma, Grade 3 Follicular Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02702141
- Run by
- Seagen Inc.
- People needed
- 44
- Starts
- 2016-02-01
- Expected to finish
- 2018-07-10
- Last updated by the study team
- 2018-08-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- City of Hope National Medical Center — Duarte, California, United States
- Mayo Clinic Florida — Jacksonville, Florida, United States
- Cardinal Bernardin Cancer Center / Loyola University Medical Center — Maywood, Illinois, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic Minnesota — Rochester, Minnesota, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- New York University (NYU) Cancer Institute — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Cleveland Clinic, The — Cleveland, Ohio, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina/Hollings Cancer Center — Charleston, South Carolina, United States
- University of Utah — Salt Lake City, Utah, United States
- Seattle Cancer Care Alliance / University of Washington — Seattle, Washington, United States
- Carbone Cancer Center / University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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