NCT02271945

Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas

A Phase 1b/2 Open-label Study to Evaluate the Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapy in Subjects With Relapsed or Refractory Aggressive B-cell Lymphomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy.

Detailed description

This is a Phase 1b/2, multicenter, open-label, study of MEDI-551 in combination with immunomodulating therapy evaluating the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity in subjects with relapsed or refractory aggressive B-cell lymphomas

Conditions

• Relapsed/Refractory Aggressive B-cell Lymphomas

Interventions

Type	Name	Description
DRUG	MEDI-551 12 mg/kg	Participants will receive intravenous (IV) infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13
DRUG	MEDI0680 2.5 mg/kg	Participants will receive IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
DRUG	MEDI0680 10 mg/kg	Participants will receive IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-05-24
• Completion: 2016-05-24
• First posted: 2014-10-22
• Last updated: 2018-03-12
• Results posted: 2018-03-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study