German biotechnology firm MorphoSys has completed the safety run-in phase of its Phase II L-MIND trial of MOR208 combined with lenalidomide, to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL).
MOR208 is an immunotherapeutic Fc-enhanced antibody that targets CD19, which is largely expressed in different B-cell malignancies such as DLBCL and chronic lymphocytic leukemia (CLL).
The Fc-enhancement of MOR208 triggers antibody-dependent, cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
The MOR208 fuses with CD19, thereby inducing a direct apoptosis.
The Phase II L-MIND trial is a single-arm, open-label, multicentre study of MOR208, involving about 80 patients with relapsed or refractory DLBCL who have two prior treatment histories, including an anti-CD20 targeting therapy (rituximab).
Patients applicable to high-dose chemotherapy and autologous stem cell transplantation are qualified for the study.
It is primarily focused to determine the overall response rate (ORR).
The secondary endpoints of the trial are to determine duration of response (DoR), progression-free survival (PFS) and overall survival (OS), as well as testing the drug combination's safety and pharmacokinetic profile of MOR208.
Six patients who had been administered with MOR208 in combination with lenalidomide have displayed no negative safety signals.
MorphoSys chief development officer Dr Arndt Schottelius said: "We continue to investigate MOR208 in combination with lenalidomide as a potential treatment for patients with DLBCL.
“This is part of our broader initiative to develop MOR208 as an antibody backbone for a variety of combination partners.
“We are pleased with the initial safety run-in results from the L-MIND trial, which showed no unexpected safety signals."
The company is planning to continue with the study.