A Clinical Study Using MEDI-551 in Adult Participants 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 Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies

The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).

To determine the MTD or OBD of MEDI-551 in participants with relapsed or refractory advanced B-cell malignancies.

Inclusion Criteria:

• Histologically confirmed CLL, DLBCL, FL, or MM;
• Karnofsky Performance Status >= 70;
• Life expectancy of >= 12 weeks;
• Prior radiation therapy provided exposure does not exceed an area of 25% of marrow space
• Adequate hematological function
• Adequate organ function

Exclusion Criteria:

• Any available standard line of therapy known to be life-prolonging or life-saving;
• No concurrent therapy or therapy within six weeks of first dose of MEDI-551 for treatment of cancer
• Previous therapy directed against CD19
• Vaccination (other than experimental cancer vaccine therapy) within 28 days prior to receiving the first dose of MEDI-551;
• History of other invasive malignancy within 5 years except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured;
• Active infection requiring treatment
• Autologous stem cell transplantation within 4 months prior to study entry;
• Allogeneic stem cell transplantation or any other organ transplant;
• Ongoing >= Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria.
• Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551;
• Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551 (inhaled and topical corticosteroids are permitted);
• Documented current central nervous system involvement by leukemia or lymphoma;
• Pregnancy or lactation;
• Clinically significant abnormality on ECG.