A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SGN-CD19B
|
Drug: SGN-CD19B
Given intravenously Day 1 of 28-day or 42-day cycles
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events [Through 1 month following last dose]
- Incidence of laboratory abnormalities [Through 1 month following last dose]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
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Measurable disease
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Eastern Cooperative Oncology Group status of 0 or 1
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Adequate baseline renal and hepatic function
Exclusion Criteria:
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Prior treatment with CD19 directed agents unless CD19 expression is confirmed after completion of CD19-directed treatment
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Known HIV, active hepatitis B or active hepatitis C infection
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Prior allogeneic stem cell transplant
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Inadequate lung function
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Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
2 | City of Hope National Medical Center | Duarte | California | United States | 91010-3000 |
3 | Mayo Clinic Florida | Jacksonville | Florida | United States | 32224 |
4 | Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
5 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
6 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
7 | Mayo Clinic Minnesota | Rochester | Minnesota | United States | 55905 |
8 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
9 | New York University (NYU) Cancer Institute | New York | New York | United States | 10016 |
10 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10021 |
11 | Cleveland Clinic, The | Cleveland | Ohio | United States | 44195 |
12 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
13 | Medical University of South Carolina/Hollings Cancer Center | Charleston | South Carolina | United States | 29425 |
14 | University of Utah | Salt Lake City | Utah | United States | 84112 |
15 | Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | United States | 98109-1023 |
16 | Carbone Cancer Center / University of Wisconsin | Madison | Wisconsin | United States | United States |
Sponsors and Collaborators
- Seagen Inc.
Investigators
- Study Director: Juan Pinelli, PA-C, MMSc, Seagen Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGN19B-001