A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Overview
- Phase
- Phase 1
- Intervention
- SGN-CD19B
- Conditions
- Non-Hodgkin Lymphoma
- Sponsor
- Seagen Inc.
- Enrollment
- 44
- Locations
- 16
- Primary Endpoint
- Incidence of adverse events
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
SGN-CD19B
Intervention: SGN-CD19B
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time Frame: Through 1 month following last dose
Secondary Outcomes
- 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)