Date: 2016-02-25
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Seattle Genetics (USA - WA)
Product: SGN-CD19B
Action
mechanism: antibody drug conjugate. SGN-CD19B is an antibody drug conjugate that targets CD19 and utilizes one of Seattle Genetics’ proprietary payloads, a pyrrolobenzodiazepine (PBD) dimer.
Disease: non-Hodgkin lymphoma, DLBCL, diffuse large B-cell lymphoma, grade 3 follicular lymphoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: 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. (NCT02702141)
Latest
news: * On February 25, 2016, Seattle Genetics announced initiation of a phase 1 clinical trial of SGN-CD19B for relapsed or refractory patients with two subtypes of B-cell non-Hodgkin lymphoma (NHL): diffuse large B-cell lymphoma (DLBCL) and grade 3 follicular lymphoma. About 85 percent of NHL is of B-cell lineage, and CD19 is broadly expressed across all subtypes of B-cell malignancies. The trial is designed to assess the safety and antitumor activity of SGN-CD19B. The study is a phase 1, open-label, multi-center, dose-escalation clinical trial. The primary endpoints are the estimation of the maximum tolerated dose and evaluation of the safety of SGN-CD19B. In addition, the trial will evaluate antitumor activity, pharmacokinetics, objective response rate and progression-free survival. The study is designed to evaluate SGN-CD19B administered every four or six weeks and will enroll up to approximately 100 relapsed or refractory patients at multiple centers in the United States. Preclinical data presented at the 2015 American Society of Hematology (ASH) Annual Meeting demonstrated that SGN-CD19B exhibits antitumor activity against a broad panel of CD19-expressing B-cell malignancies, inducing durable tumor regressions in multiple preclinical models of NHL and B-ALL.
