Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGN-CD19B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-CD19B | Drug | Given intravenously Day 1 of 28-day or 42-day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Through 1 month following last dose | |
| Incidence of laboratory abnormalities | Through 1 month following last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations of SGN-CD19B | Through 3 weeks after dosing | |
| Incidence of antitherapeutic antibodies | Through 1 month following last dose | |
| Objective response rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan Pinelli, PA-C, MMSc | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28903943 | Derived | Ryan MC, Palanca-Wessels MC, Schimpf B, Gordon KA, Kostner H, Meyer B, Yu C, Van Epps HA, Benjamin D. Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Blood. 2017 Nov 2;130(18):2018-2026. doi: 10.1182/blood-2017-04-779389. Epub 2017 Sep 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Through 1 month following last dose |
| Rate of response | Through 1 month following last dose |
| Progression-free survival | Up to approximately 3 years |
| Duarte |
| California |
| 91010-3000 |
| United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| New York University (NYU) Cancer Institute | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina/Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | 98109-1023 | United States |
| Carbone Cancer Center / University of Wisconsin | Madison | Wisconsin | United States | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C000624559 | SGN-CD19B |
Not provided
Not provided
Not provided