Non Hodgkin Lymphoma Clinical Trial
A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
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.
Full 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.
Eligibility 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
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There are 15 Locations for this study
Birmingham Alabama, 35294, United States
Duarte California, 91010, United States
Jacksonville Florida, 32224, United States
Maywood Illinois, 60153, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Hackensack New Jersey, 07601, United States
New York New York, 10016, United States
New York New York, 10021, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19107, United States
Charleston South Carolina, 29425, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Madison Wisconsin, Unite, United States
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