Clinical trial NCT02702141: A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Hodgkin Lymphoma
DLBCL
Diffuse Large B-cell Lymphoma
Grade 3 Follicular Lymphoma
Keywords: Non-hodgkin lymphoma
Antibody-drug conjugate
CD19
Diffuse large B-cell lymphoma
DLBCL
Grade 3 follicular lymphoma
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through 1 month following last dose
measure: Incidence of laboratory abnormalities
timeFrame: Through 1 month following last dose
Secondary outcomes:
measure: Blood concentrations of SGN-CD19B
timeFrame: Through 3 weeks after dosing
measure: Incidence of antitherapeutic antibodies
timeFrame: Through 1 month following last dose
measure: Objective response rate
timeFrame: Through 1 month following last dose
measure: Rate of response
timeFrame: Through 1 month following last dose
measure: Progression-free survival
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University (NYU) Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic, The
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina/Hollings Cancer Center
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
city: Madison
country: United States
facility: Carbone Cancer Center / University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Seagen Inc.
name: Juan Pinelli, PA-C, MMSc
role: STUDY_DIRECTOR
References:
citation: 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.