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

NCT01685008 | Completed Phase 2 Results

• 2 other identifiers: MOR208C2012012-002659-41
• Study Type: interventional
• Target: 92
• Locations: 7 countries
• Sites: 22

Brief Summary

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).

Conditions

Non-Hodgkin Lymphoma

Keywords

NHL; CD19; MOR208; MOR00208; Xmab5574; B-Cell Non-Hodgkin´s Lymphoma; Fc-optimized Anti-CD19 Antibody; Tafasitamab

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Proportion of patients with Complete Remission (CR; disappearance of all evidence of disease) or Partial Remission (PR; regression of measurable disease and no new sites), assessed as per the 2007 International Working Group (IWG) response criteria by radiographic evaluations (CT, PET, MRI, or other).

  From first dose until Follow-up Visit 12, up to 4.5 years

Secondary Outcomes (27)

• Stable Disease (SD) Rate

  From first dose until Follow-up Visit 12, up to 4.5 years

• Duration of Response (DoR)

  From first dose until Follow-up Visit 12, up to 4.5 years

• Time to Progression (TTP)

  From first dose until Follow-up Visit 12, up to 4.5 years

• Progression-free Survival (PFS)

  From first dose until Follow-up Visit 12, up to 4.5 years

• Incidence and Severity of Adverse Events (AEs)

  From first dose until 30 days after last dose of MOR00208, up to 8.5 years

Study Arms (1)

MOR00208 (formerly Xmab5574)

EXPERIMENTAL

intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody

Drug: MOR00208 (formerly Xmab 5574)

Interventions

MOR00208 (formerly Xmab 5574) DRUG

Also known as: MOR208

MOR00208 (formerly Xmab5574)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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.

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.

Sponsors & Collaborators

• MorphoSys AG: lead

Study Sites (22)

MorphoSys Research Site

Norwalk, Connecticut, 06856, United States

Location

MorphoSys Research Site

Hackensack, New Jersey, 07601, United States

Location

Morphosys Research Site

Columbus, Ohio, 43201, United States

Location

Morphosys Research Site

Lubbock, Texas, 79410, United States

Location

MorphoSys Research Site

Brussels, Belgium

Location

MorphoSys Research Site

Edegem, Belgium

Location

MorphoSys Research Site

Berlin, Germany

Location

MorphoSys Research Site

Mainz, Germany

Location

Morphosys Research Site

Ulm, Germany

Location

Morphosys Research Site

Budapest, Hungary

Location

Morphosys Research Site

Debrecen, Hungary

Location

MorphoSys Research Site

Bologna, Italy

Location

MorphoSys Research Site

Florence, Italy

Location

Morphosys

Genova, Italy

Location

Morphosys Research Site

Modena, Italy

Location

Morphosys Research Site

Novara, Italy

Location

MorphoSys Research Site

Chorzów, Poland

Location

Morphosys Research Site

Krakow, Poland

Location

Morphosys Research Site

Lódz, Poland

Location

MorphoSys Research Site

Słupsk, Poland

Location

Morphosys Research Site

Madrid, Spain

Location

Morphosys Research Site

Seville, Spain

Location

Related Publications (1)

• Jurczak W, Zinzani PL, Gaidano G, Goy A, Provencio M, Nagy Z, Robak T, Maddocks K, Buske C, Ambarkhane S, Winderlich M, Dirnberger-Hertweck M, Korolkiewicz R, Blum KA. Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Ann Oncol. 2018 May 1;29(5):1266-1272. doi: 10.1093/annonc/mdy056.

  PMID: 29444231 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

tafasitamab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Medical Information
• Organization: MorphoSys AG

medinfo@morphosys.com

+1 844 667-1992

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 13, 2012
• Study Start: April 23, 2013
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-10

Locations

PL (4); DE (3); HU (2); BE (2); US (4); IT (5); ES (2)