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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Blood Cancer; Advanced B Cell Malignancies

Treatments: Drug: MEDI-551

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957579

D2850C00001

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

MEDI-551

Experimental group

Treatment:

Drug: MEDI-551