A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

Conditions
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Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B-cell Lymphoma, Grade 3 Follicular Lymphoma

Intervention / Treatment
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* Drug: SGN-CD19B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGN-CD19B<br> | Drug: SGN-CD19B<br>* Given intravenously Day 1 of 28-day or 42-day cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Through 1 month following last dose | 
| Incidence of laboratory abnormalities |  | Through 1 month following last dose | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Through 1 month following last dose | 
| Rate of response |  | Through 1 month following last dose | 
| Progression-free survival |  | Up to approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-hodgkin lymphoma, Antibody-drug conjugate, CD19, Diffuse large B-cell lymphoma, DLBCL, Grade 3 follicular lymphoma