Diffuse Large B-cell Lymphoma, DLBCL, Grade 3 Follicular Lymphoma, Non-Hodgkin Lymphoma
Conditions
Keywords
Non-hodgkin lymphoma, Antibody-drug conjugate, CD19, Diffuse large B-cell lymphoma, DLBCL, Grade 3 follicular lymphoma
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.
Interventions
DRUGSGN-CD19B
Given intravenously Day 1 of 28-day or 42-day cycles
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Through 1 month following last dose |
| Incidence of laboratory abnormalities | Through 1 month following last dose |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | Through 1 month following last dose |
| Blood concentrations of SGN-CD19B | Through 3 weeks after dosing |
| Progression-free survival | Up to approximately 3 years |
| Rate of response | Through 1 month following last dose |
| Incidence of antitherapeutic antibodies | Through 1 month following last dose |
Countries
United States
Outcome results
None listed