German biotechnology firm MorphoSys has initiated patient enrolment for the Phase III part of the Phase II/III B-MIND clinical trial of MOR208 and bendamustine combination to treat diffuse large B-cell lymphoma (DLBCL).
MOR208 is an investigational, Fc-enhanced monoclonal antibody currently being developed to target CD19 in B-cell malignancies.
The randomised, multi-centre Phase III trial is estimated to recruit a total of up to 330 patients at approximately 180 centres in Europe, Asia Pacific (APAC) and the US.
The Phase II/III trial is designed to compare the efficacy of MOR208 and bendamustine combination with rituximab and bendamustine combination in relapsed or refractory DLBCL patients who are ineligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).
MorphoSys chief development officer Dr Malte Peters said: "For patients with relapsed or refractory DLBCL who are not eligible for HDC and ASCT, current treatment options are limited.
“In our pivotal B-MIND study, we are therefore exploring MOR208 in combination with bendamustine as a potential treatment alternative for this difficult-to-treat patient group.”
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The initiation of the Phase III part follows a recommendation from the independent data monitoring committee (IDMC), based on data from the Phase II safety evaluation part.
The Phase III trial will include patients who previously received treatment with a minimum of one and not more than three lines of therapy, including one anti-CD20 targeted therapy.
MorphoSys holds the worldwide rights to MOR208 and licensed the product from Xencor in 2010.
Dosing initiation during this part of the trial is set to trigger an undisclosed milestone payment to Xencor.