A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies

A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies

The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.

Inclusion Criteria:

• Japanese men or women at least 20 years of age
• Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM.
• Karnofsky Performance Status ≥70;
• Life expectancy of ≥12 weeks

Exclusion Criteria:

• Any available standard line of therapy known to be life-prolonging or life-saving
• Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
• Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates