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

• Status: Completed
• Trial end date: 2015-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: MedImmune LLC

Criteria

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