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Active clinical trials

MorphoSys is committed to developing innovative antibody therapies with the potential to improve patients’ lives. 

Smart development strategies that respect the patient’s needs are central to our drug development approach.

MOR208
(anti-CD19)

MOR208 (formerly XmAb®5574) is an Fc-enhanced monoclonal antibody directed against the antigen CD19 which is broadly expressed on the surface of B cells. It is therefore an important factor for the treatment of B cell malignancies, such as non-Hodgkin’s lymphoma (NHL), including diffuse large B cell lymphoma (DLBCL), as well as chronic lymphocytic leukemia (CLL). Fc-modification of MOR208 is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus possibly improving a key mechanism of tumor cell killing. Furthermore, MOR208 induces direct apoptosis by binding to CD19 which is a crucial component for B cell receptor (BCR) signaling.

MorphoSys is investigating MOR208 as an immunotherapeutic option in B cell malignancies.

Background

B-MIND STUDy

The randomized, double-arm, open-label, multicenter phase 2/3 B-MIND (bendamustine - MOR208 in DLBCL) study is expected to enroll approximately 330 patients in about 180 centers in Europe, Asia Pacific (APAC) and the USA. At the time of study entry, patients must present with relapsed or refractory DLBCL, which has previously been treated with at least one and not more than three prior lines of therapy, including one anti-CD20 targeting therapy (e.g. rituximab). Patients must not be eligible for high-dose chemotherapy and autologous stem cell transplantation.
The phase 2 safety evaluation part of the study will assess the safety and tolerability of MOR208 plus bendamustine vs. the rituximab plus bendamustine combination, enrolling approximately 10 patients in each treatment arm.
Following the safety evaluation part, the trial is intended to be transitioned into the pivotal phase 3 part, expected to start in 2017. 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), time to progression (TTP) as well as an evaluation of patients' quality of life (QoL).

L-MIND study

L-MIND (lenalidomide - MOR208 in DLBCL) is a single-arm, open-label, multicenter study of the anti-CD19 antibody MOR208 in combination with lenalidomide enrolling 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 (e.g. 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 MOR208.

COSMOS STUDY

The COSMOS-Study (CLL patients assessed for ORR & Safety in MOR208 Study) is a single-arm, open-label, multicenter combination trial of MOR208 with idelalisib in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Patient enrolled must have been refractory or shown relapse or intolerance to a prior, most recent, therapy with a Bruton's Tyrosine Kinase (BTK) inhibitor (e.g. ibrutinib). The study's primary endpoint, that enrolls patents in Europe and the USA, is overall response rate (ORR). Secondary outcome measures include progression-free survival (PFS), overall survival (OS) and duration of response (DoR), as well as an evaluation of the drug combination's safety and pharmacokinetic parameters of MOR208.

MOR202
(anti-CD38)

MOR202 is a fully human monoclonal antibody directed against CD38, which is one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells, and is an established diagnostic marker for multiple myeloma. Because of this expression pattern, an anti-CD38 antibody may have clinical utility as a new therapeutic approach to multiple myeloma treatment. Antibody-dependent cell-mediated cytotoxicity (ADCC) is the primary mode of action of MOR202.

The program is currently being evaluated in a phase 1/2a clinical trial, which will investigate MOR202’s safety, tolerability and preliminary activity in patients with relapsed/refractory multiple myeloma.

Background

Phase 1/2a study (MM)

This is an ongoing clinical phase 1/2a, open-label, multi-center, dose-escalation study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 alone and in combination with the immunomodulatory drugs pomalidomide (Pom) and lenalidomide (Len) plus dexamethasone (Dex) in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 alone and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.

MOR103/GSK3196165

MOR103/GSK3196165 is a fully human HuCAL-antibody directed against GM-CSF (Granulocyte-macrophage colony-stimulating factor). As the compund has been fully out-licensed to GSK in 2013, GSK is fully responsible for the further clinical development of MOR103/GSK3196165.

MOR209/ES414
(bispecific, anti-PSMA/-CD3)

The immunotherapeutic protein activates the patients’ T cell immunity specifically against prostate cancer cells expressing Prostate Specific Membrane Antigen (PSMA), an antigen commonly overexpressed in this tumor. The anti-CD3 domains of the molecule selectively bind to the T cell receptor on cytotoxic T cells which become activated when the anti-PSMA domains crosslink them to the cancer cells. The two pairs of binding domains of MOR209/ES414 are linked to opposite ends of an immunoglobulin Fc domain to extend the half-life and enable the use of a purification process typical of lg-based molecules.

 

Background

Phase 1 Study (mCRPC)

The study will be conducted in two stages. The primary objective of stage 1 is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously to patients with mCRPC. The secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of MOR209/ES414. Within stage 2, the primary objective is to evaluate clinical activity in patients that have or have not received prior chemotherapy, while secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of MOR209/ES414.

MOR106
(IL-17C)

MOR106 is a human monoclonal IL-17C antibody for the treatment of atopic dermatitis. MOR106 arises from the alliance initiated by Galapagos and MorphoSys. Galapagos provides the disease-related biology including cellular assays and targets discovered using its target discovery platform. MorphoSys contributes its Ylanthia antibody technology to generate fully human antibodies directed against the target and contributes full CMC development of this compound. Galapagos and MorphoSys will continue to jointly investigate MOR106 in clinical development.

Background

Phase 1 Study

The primary objective of the randomized, double-blind, placebo-controlled phase 1 study is to evaluate the safety and tolerability of MOR106. As secondary endpoints, the study will assess pharmacokinetics and potential immunogenicity of MOR106.

The first part of the study started in April 2016. It is being conducted as a single center study in 56 healthy volunteers, evaluating single ascending doses (SAD) of MOR106 as intravenous infusion compared to placebo. MOR106 has shown favorable safety and PK results administered to healthy volunteers. In September 2016 the second part of the study started, investigating multiple ascending doses (MAD) of MOR106 compared to placebo in approximately 24 patients with moderate to severe atopic dermatitis in several European study centers.

MOR107

MOR107, a selective agonist of the angiotensin II receptor type 2, is a lanthipeptide based on Lanthio Pharma’s proprietary technology platform and the first lanthipeptide in MorphoSys’s clinical pipeline.

Background

phase 1 study

The goal of the trial is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered single ascending doses (SAD) of MOR107 in healthy male volunteers.

The randomized, double-blind, placebo-controlled phase 1 study will be conducted in a single center in the United Kingdom and will enroll 80-110 subjects.

Topline results of the study are expected in the second half of 2017.

Physicians and Patients

Physicians interested in learning more about MorphoSys-sponsored clinical trials should contact: clinicalstudies@morphosys.com.

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

Disclaimer
MorphoSys’s product candidates are investigational and are currently not approved for the treatment of any disease or condition anywhere in the world. They cannot be prescribed or purchased for therapy at present.
The MorphoSys website may contain information on drug candidates and clinical trials sponsored by MorphoSys with the intention of increasing the transparency of the company’s clinical research.
Information contained within this website is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment.
All reasonable precautions have been taken to ensure the accuracy, security and confidentiality of information available through the site. MorphoSys may amend the information at any time without notice.

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