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

• Status: Completed
• Trial end date: 2019-03-21
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Antibodies, Monoclonal; Rituximab

Criteria

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.