CLINICAL
TRIALS

The possibility of future treatments begins here

The possibility of future treatments begins here

More than 20 therapeutic antibodies are being evaluated by MorphoSys and its partners in clinical trials as potentially novel treatment options for severe and life-threatening diseases.

MorphoSys continues to expand its portfolio of unique drug candidates and is looking for partners with innovative targets, supportive technologies, and promising antibodies for further development.

Physicians interested in learning more about clinical trials sponsored by MorphoSys should contact us at medical@morphosys.com.

For a full list of our therapeutic pipeline and clinical trials, visit morphosys.com/pipeline

Patients are kindly asked to contact their treating physicians if they are interested in participating in any of MorphoSys’ clinical trials.

Drawing of a microscope

Currently active clinical trials

Phase 2 - L-MIND Study

View L-MIND on ClinicalTrials.gov

L-MIND (lenalidomide - MOR208 in relapsed or refractory diffuse large B-cell lymphoma [R/R DLBCL]) is a phase 2 single-arm, open-label, multicenter study of tafasitamab-cxix (MOR208) in combination with lenalidomide in approximately 80 patients with relapsed or refractory DLBCL after at least one, but no more than three, prior lines of therapy, including an anti-CD20 targeting therapy (eg, rituximab).

Patients must not be candidates for high-dose chemotherapy and autologous stem cell transplantation.

The study’s primary endpoint is overall response rate (ORR).

Secondary outcome measures include duration of response (DoR), progression-free survival (PFS), and overall survival (OS), as well as an evaluation of the drug combination’s safety and pharmacokinetic parameters of tafasitamab (MOR208).

The data from the primary analysis of L-MIND were presented in June 2019.

The randomized, double-arm, open-label, multicenter phase 2/3 B-MIND (bendamustine - MOR208 in relapsed or refractory diffuse large B-cell lymphoma [R/R DLBCL]) study was initiated in 2016 and is expected to enroll patients in up to 180 centers in Europe, Asia Pacific (APAC), and the USA.

The trial enrolls patients with relapsed or refractory DLBCL, who have previously been treated with at least one and not more than three prior lines of therapy, including one anti-CD20 targeting therapy (eg, the antibody rituximab).

Patients must not be eligible for high-dose chemotherapy and autologous stem cell transplantation.

The phase 2 safety evaluation part of the study to assess the safety and tolerability of tafasitamab (MOR208) plus bendamustine vs the rituximab plus bendamustine combination was completed in mid-2017.

In June 2017, the study was transitioned into the pivotal phase 3 part. The primary endpoint of the study is progression-free survival (PFS).

Secondary outcome measures will include objective response rate (ORR), duration of response (DoR), overall survival (OS), disease control rate (DCR), and time to progression (TTP), as well as an evaluation of patients’ quality of life (QoL).

In Q1 2019, MorphoSys has implemented an amendment of the B-MIND study in agreement with the FDA, which adds a biomarker-based co-primary endpoint to the original study protocol. In November 2019, B-MIND passed a futility analysis.

Based on the recommendation from an independent data monitoring committee, the number of patients in the study will be increased to 450.

First-MIND is an open-label, randomized, multicenter phase 1b study to evaluate safety and preliminary efficacy of tafasitamab in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone) as well as tafasitamab and lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated DLBCL.

Patients enrolled in each arm will receive six cycles of treatment.

The primary endpoint is the incidence and severity of treatment-emergent adverse events (AEs). Key secondary endpoints are objective response rate (ORR) and PET-negative complete response (CR) rate at the end of treatment.

The COSMOS study (CLL patients assessed for ORR & safety in MOR208 study) is a single-arm, open-label, multicenter phase 2 combination trial of tafasitamab (MOR208) with either idelalisib or venetoclax in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Patients enrolled must have been refractory or shown relapse or intolerance to a prior and most recent therapy with a Bruton’s tyrosine kinase (BTK) inhibitor (eg, ibrutinib).

The study primarily evaluates the safety of the drug combinations.

In 2019, MorphoSys presented data of the primary analysis of the COSMOS trial at the American Society of Hematology.