A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
1 other identifier
interventional
44
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2016
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2018
CompletedAugust 13, 2018
August 1, 2018
2.4 years
February 25, 2016
August 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events
Through 1 month following last dose
Incidence of laboratory abnormalities
Through 1 month following last dose
Secondary Outcomes (5)
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
Study Arms (1)
SGN-CD19B
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, 60153, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New York University (NYU) Cancer Institute
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Cleveland Clinic, The
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, 29425, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States, United States
Related Publications (1)
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.
PMID: 28903943DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Juan Pinelli, PA-C, MMSc
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 8, 2016
Study Start
February 1, 2016
Primary Completion
July 10, 2018
Study Completion
July 10, 2018
Last Updated
August 13, 2018
Record last verified: 2018-08