Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)

Completed · Phase 2

Conditions studied: Non-Hodgkin Lymphoma

In brief

This is an open-label, multicenter study to characterize the safety and efficacy of the human anti-CD19 antibody MOR00208 in adult patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) who have received at least 1 prior therapy containing rituximab (at least once).

Key facts

Study ID

NCT01685008

Run by

MorphoSys AG

People needed

92

Starts

2013-04-23

Expected to finish

2022-04-06

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 18 years of age.
• Histologically-confirmed diagnosis according to Revised European American Lymphoma/World Health Organization classification, of the following B-cell lymphomas:
• FL
• Other indolent NHL (eg, MZL/MALT)
• DLBCL
• MCL
• Patients' NHL must have progressed after at least 1 prior rituximab containing regimen.
• One site of measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan defined as at least one lesion that measures at least 1.5 × 1.5 cm.
• Exception:
• For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled.
• Patients who have previously received an autologous stem cell transplantation must be at least 4 weeks post-transplant before study drug administration and must have exhibited a full haematological recovery.
• Discontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration.
• Off rituximab for at least 14 days before the screening visit and be confirmed to have either no response or have disease progression after rituximab treatment.
• Patients with DLBCL had a positive [18F]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at baseline (Cheson 2007 response criteria).
• Life expectancy of > 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of < 3.
• Laboratory criteria at screening:
• Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L
• Platelet count ≥ 75 × 10\^9/L without previous transfusion within 10 days of first study drug administration
• Haemoglobin ≥ 8.0 g/dL (may have been transfused)
• Serum creatinine < 2.0 x upper limit of normal (ULN)
• Total bilirubin ≤ 2.0 × ULN
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
• If a female of childbearing potential, a negative pregnancy test must be confirmed before enrolment and use of double-barrier contraception or oral contraceptive plus barrier contraceptive must be used during the study and for 3 months after the last dose, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.
• If a male, an effective barrier method of contraception must be used during the study and for 3 months after the last dose if the patient is sexually active with a female of childbearing potential.

You may not qualify if…

• Previous treatment with cytotoxic chemotherapy, immunotherapy, radiotherapy or other lymphoma specific therapy within 14 days before the screening visit or patient has not recovered from side effects of previous lymphoma-specific therapy.
• Treatment with a systemic investigational agent within 28 days before the screening visit.
• Previous treatment with an anti-CD19 antibody or fragments.
• Previous allogenic stem cell transplantation.
• Known or suspected hypersensitivity to the excipients contained in the study drug formulation.
• Clinically significant cardiovascular disease or cardiac insufficiency, cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris within 3 months of enrolment.
• Patients with positive hepatitis serology:
• Hepatitis B (HBV): Patients with positive serology for HBV defined as positivity for hepatitis B surface antigen (HBsAg) or total anti-hepatitis B core antibody (anti-HBc). Patients positive for anti-HBc may be included if HBV DNA is not detectable.
• Hepatitis C (HCV): Patients positive HCV serology (defined as positive for anti-HCV antibody [anti-HCV]) unless HCV-ribonucleic acid (RNA) is confirmed negative.
• History of HIV infection.
• Any active systemic infection (viral, fungal, or bacterial) requiring active parenteral antibiotic therapy within 4 weeks of study drug administration.
• Current treatment with immunosuppressive agents other than prescribed corticosteroids (not more than 10-mg prednisone equivalent).
• Major surgery or radiation therapy within 4 weeks before first study drug administration.
• Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.
• History or clinical evidence of central nervous system (CNS), meningeal, or epidural disease, including brain metastasis.
• Active treatment/chemotherapy for another primary malignancy within the past 5 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ).
• Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control.
• History of noncompliance to medical regimens or patients who are considered potentially unreliable not cooperative.

Where it is running

• MorphoSys Research Site — Norwalk, Connecticut, United States
• MorphoSys Research Site — Hackensack, New Jersey, United States
• Morphosys Research Site — Columbus, Ohio, United States
• Morphosys Research Site — Lubbock, Texas, United States
• MorphoSys Research Site — Brussels, Belgium
• MorphoSys Research Site — Edegem, Belgium
• MorphoSys Research Site — Berlin, Germany
• MorphoSys Research Site — Mainz, Germany
• Morphosys Research Site — Ulm, Germany
• Morphosys Research Site — Budapest, Hungary
• Morphosys Research Site — Debrecen, Hungary
• MorphoSys Research Site — Bologna, Italy
• MorphoSys Research Site — Florence, Italy
• Morphosys — Genova, Italy
• Morphosys Research Site — Modena, Italy
• Morphosys Research Site — Novara, Italy
• MorphoSys Research Site — Chorzów, Poland
• Morphosys Research Site — Krakow, Poland
• Morphosys Research Site — Lódz, Poland
• MorphoSys Research Site — Słupsk, Poland
• Morphosys Research Site — Madrid, Spain
• Morphosys Research Site — Seville, Spain

Full record on ClinicalTrials.gov

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