A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
- Conditions
- Non-Hodgkin LymphomaGrade 3 Follicular LymphomaDLBCLDiffuse Large B-cell Lymphoma
- Interventions
- Registration Number
- NCT02702141
- Lead Sponsor
- Seagen Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SGN-CD19B SGN-CD19B -
- Primary Outcome Measures
Name Time Method Incidence of adverse events Through 1 month following last dose Incidence of laboratory abnormalities Through 1 month following last dose
- Secondary Outcome Measures
Name Time Method Blood concentrations of SGN-CD19B Through 3 weeks after dosing Incidence of antitherapeutic antibodies Through 1 month following last dose Objective response rate Through 1 month following last dose Rate of response Through 1 month following last dose Progression-free survival Up to approximately 3 years
Trial Locations
- Locations (16)
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Medical University of South Carolina/Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
New York University (NYU) Cancer Institute
🇺🇸New York, New York, United States
Carbone Cancer Center / University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, 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
Cleveland Clinic, The
🇺🇸Cleveland, Ohio, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Seattle Cancer Care Alliance / University of Washington
🇺🇸Seattle, Washington, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States