A Phase Ib/II open-label study to evaluate the safety and efficacy of MEDI-551 in combination with immunomodulating therapy in patients with relapsed or refractory aggressive B cell lymphomas

Background MEDI-551, an IgG1k antibody-dependent cellular cytotoxicity (ADCC) enhanced anti-CD19 monoclonal antibody (mAb), has a single-agent response rate of 24% (12% with complete remission [CR]) in heavily pretreated patients with diffuse large B cell lymphoma (DLBCL). MEDI0680 (AMP-514) a humanized IgG4 mAb against PD-1, blocks inhibitory PD-1 receptors (PD-L1) on T cells to augment immune responses. A combination of MEDI-551/MEDI0680 (AMP-514) may link the intrinsic cytotoxic capability of MEDI-551 with an agent that primes the immune cells required for ADCC or may augment immune responses from tumor cell death by MEDI-551. This study explores this novel combination regimen in patients with multiply relapsed/ refractory (R/R) DLBCL who have limited opportunities for cure, and may offer a regimen with less toxicity but equal or better efficacy versus traditional chemotherapy. Study D2852C00004, a Phase Ib/2 dose escalation/ expansion study, will determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (HPDD) safety, and activity of the combination of MEDI-551/MEDI0680 (AMP-514) in R/R DLBCL patients who have failed 1-2 prior lines of therapy.