SGN19A-001

DrugSGN19A
Drug DescriptionSGN-CD19A is an antibody-drug conjugate (ADC) targeting CD19, a protein expressed on acute lymphoblastic leukemia and some types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, as well as on certain healthy cells of the immune system. We have reported preclinical data demonstrating that SGN-CD19A effectively binds to target cells, internalizes and induces potent cell-killing activity and durable tumor regressions at low doses in multiple cancer models.
Trial/StudySGN19A-001
Trial/Study PhasePhase I
Trial/Study SponsorSeattle Genetics, Inc.
Trial/Study (Abbreviated) TitleA Safety Study of SGN-CD19A for Leukemia and Lymphoma
Trial/Study (Official) TitleA Phase I, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas (NCT01786096)
Trial/Study Design
  • Endpoint Classification: Safety Study
  • Intervention Model: Single Group Assignment
  • Masking: Open Label, single arm
  • Primary Purpose: Treatment
Trial/Study Design DescriptionPatient will receive SGN-CD19A once (Day 1) or twice (Day 1 and 8) by intravenous (IV) infusion every 21 days; dose range: 0.3-6 mg/kg
Trial/Study DescriptionThis is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).
Trial/Study TypeInterventional
Condition
  • Burkitt Lymphoma
  • Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Primary Objectives
  • Estimate the maximum tolerated dose in adult and pediatric patients
  • Evaluate the safety and tolerability
Secondary Objectives
  • Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)
  • Estimate the progression-free survival and overall survival
  • Assess pharmacokinetics and immunogenicity

Last Editorial Review: February 10, 2015