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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02702141
• Other study ID #: SGN19B-001
• Status: Terminated
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: July 10, 2018

Study information

• Verified date: August 2018
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• SGN-CD19B
Given intravenously Day 1 of 28-day or 42-day cycles

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Medical University of South Carolina/Hollings Cancer Center	Charleston	South Carolina
United States	Cleveland Clinic, The	Cleveland	Ohio
United States	City of Hope National Medical Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Carbone Cancer Center / University of Wisconsin	Madison	Wisconsin
United States	Cardinal Bernardin Cancer Center / Loyola University Medical Center	Maywood	Illinois
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University (NYU) Cancer Institute	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic Minnesota	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Through 1 month following last dose
Primary	Incidence of laboratory abnormalities		Through 1 month following last dose
Secondary	Blood concentrations of SGN-CD19B		Through 3 weeks after dosing
Secondary	Incidence of antitherapeutic antibodies		Through 1 month following last dose
Secondary	Objective response rate		Through 1 month following last dose
Secondary	Rate of response		Through 1 month following last dose
Secondary	Progression-free survival		Up to approximately 3 years