Non-Hodgkin LymphomaPhase 2NCT01685008
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study testing MOR00208 (formerly Xmab 5574) in people with Non-Hodgkin Lymphoma, run by MorphoSys AG at 22 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- MOR00208 (formerly Xmab 5574)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 23 Apr 2013to 6 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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.
- Able to comply with all study-related procedures, medication use, and evaluations.
- Able to understand and give written informed consent and comply with the study protocol.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
Italy5 sites
MorphoSys Research Site
Bologna
MorphoSys Research Site
Florence
Morphosys
Genova
Morphosys Research Site
Modena
Morphosys Research Site
Novara
United States4 sites
Morphosys Research Site
Columbus, Ohio, 43201
MorphoSys Research Site
Hackensack, New Jersey, 07601
Morphosys Research Site
Lubbock, Texas, 79410
MorphoSys Research Site
Norwalk, Connecticut, 06856
Poland4 sites
MorphoSys Research Site
Chorzów
Morphosys Research Site
Krakow
Morphosys Research Site
Lódz
MorphoSys Research Site
Słupsk
Germany3 sites
MorphoSys Research Site
Berlin
MorphoSys Research Site
Mainz
Morphosys Research Site
Ulm
Hungary2 sites
Morphosys Research Site
Budapest
Morphosys Research Site
Debrecen
About this study
Official title: A Phase IIa, Open-label, Multicenter Study of Single-agent MOR00208, an Fc-optimized Anti-CD19 Antibody, in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
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).
Read the detailed description
The study enrols patients from four different NHL subtypes: follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other indolent NHL (iNHL). The study will employ a two-stage design where the decision to further enrol any NHL subtype in stage 2 will depend on best responses after two or three cycles in stage 1.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- MOR00208 (formerly Xmab 5574)
- Keywords
- NHL, CD19, MOR208, MOR00208, Xmab5574, B-Cell Non-Hodgkin´s Lymphoma, Fc-optimized Anti-CD19 Antibody, Tafasitamab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOR00208 (formerly Xmab 5574)Drug
Also called MOR208
| Study group | Role | What they receive |
|---|---|---|
| MOR00208 (formerly Xmab5574) | Experimental | intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody Receives: Drug: MOR00208 (formerly Xmab 5574) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Secondary outcomes (27)
Stable Disease (SD) Rate
Proportion of patients with Stable Disease (failure to attain CR/PR with no progressive disease)
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Duration of Response (DoR)
Time from first CR or PR to first documentation of relapse/progression (any new lesion or increase by ≥ 50% of previously identified site)
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Time to Progression (TTP)
Time from first dosing until documentation of progression or death due to lymphoma
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Progression-free Survival (PFS)
Time from first dosing until progression or death due to any case
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Incidence and Severity of Adverse Events (AEs)
Number of patients with treatment-emergent AEs rated Mild, Moderate, and Severe
Measured: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Number of patients with at least one positive (+ve) post-Baseline sample containing positive anti-MOR00208 antibodies; Baseline (pre-dose) sample has to be tested negative (-ve)
Measured: From first dose until Follow-up Visit 3, up to 7 months
Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208
The highest concentration of MOR00208 measured in serum
Measured: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208
The time to highest concentration of MOR00208 measured in serum
Measured: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208
The last quantifiable concentration from the first dose of MOR00208
Measured: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208
Area under the concentration curve. The time curve from time zero (0) to the time that the last concentration above the lower limit of quantification (LLQ) is observed.
Measured: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208
Area under the concentration curve. The time curve from time zero (0) to infinity (inf), where infinity is computed from AUC0-t + [Ct/λZ)]. Ct is calculated from the concentration at the last sampling time at which the sample is above LLQ.
Measured: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208
Apparent terminal rate constant calculated from the regression analysis (slope) from the log-transformed measured concentrations on the terminal phase of the time-point concentration curve
Measured: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208
Apparent terminal half-life calculated from ln(2)/λz
Measured: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Total Body Clearance (CL) of MOR00208
Total body clearance calculated for single or multiple doses: dose(s)/AUC(0-inf)
Measured: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208
Apparent volume of distribution during the terminal phase, calculated from dose/(AUC(0-inf)*λz)
Measured: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
Absolute Change From Baseline in Measurements of B-cell Populations
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Measured: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Percent Change From Baseline in Measurements of B-cell Populations
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Measured: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Absolute Change From Baseline in Measurements of T-cell Populations
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Measured: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Percent Change From Baseline in Measurements of T-cell Populations
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Measured: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Absolute Change From Baseline in Measurements of NK Cell Populations
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Measured: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Percent Change From Baseline in Measurements of NK Cell Populations
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Measured: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Evaluation of AEs Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
Incidence of AEs as stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
Measured: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Evaluation of ORR Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
The analysis of the primary endpoint (ORR) will additionally be stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Evaluation of AEs Stratified by FcγRIIa Polymorphism
Incidence of AEs as stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Measured: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Evaluation of AEs Stratified by FcγRIIIa Polymorphism
Incidence of AEs as stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Measured: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Evaluation of ORR Stratified by FcγRIIa Polymorphism
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Evaluation of ORR Stratified by FcγRIIIa Polymorphism
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Measured: From first dose until Follow-up Visit 12, up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study start23 Apr 2013
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- MorphoSys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685008
- Sponsor's protocol ID
- MOR208C201
- Other IDs
- 2012-002659-41
- Status last verified
- Oct 2023
- First submitted
- 3 Sep 2012
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29444231
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Open-label, Multicenter Study of Single-agent MOR00208, an Fc-optimized Anti-CD19 Antibody, in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01685008
- Acronym / sponsor ID
- MOR208C201
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- NHL, CD19, MOR208, MOR00208, Xmab5574, B-Cell Non-Hodgkin´s Lymphoma, Fc-optimized Anti-CD19 Antibody, Tafasitamab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- MorphoSys AGIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2013 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study enrols patients from four different NHL subtypes: follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other indolent NHL (iNHL). The study will employ a two-stage design where the decision to further enrol any NHL subtype in stage 2 will depend on best responses after two or three cycles in stage 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOR00208 (formerly Xmab5574) | Experimental | Drug: MOR00208 (formerly Xmab 5574)intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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:
- 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.
- For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOR00208 (formerly Xmab 5574)Also: MOR208 | Drug | MOR00208 (formerly Xmab5574) |
Primary outcome
Overall Response Rate (ORR)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
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).
27 secondary outcomes
Stable Disease (SD) Rate
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Duration of Response (DoR)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Time to Progression (TTP)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Progression-free Survival (PFS)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Incidence and Severity of Adverse Events (AEs)
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Time frame: From first dose until Follow-up Visit 3, up to 7 months
Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Total Body Clearance (CL) of MOR00208
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
Absolute Change From Baseline in Measurements of B-cell Populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Percent Change From Baseline in Measurements of B-cell Populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Absolute Change From Baseline in Measurements of T-cell Populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Percent Change From Baseline in Measurements of T-cell Populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Absolute Change From Baseline in Measurements of NK Cell Populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Percent Change From Baseline in Measurements of NK Cell Populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Evaluation of AEs Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Evaluation of ORR Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Evaluation of AEs Stratified by FcγRIIa Polymorphism
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Evaluation of AEs Stratified by FcγRIIIa Polymorphism
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Evaluation of ORR Stratified by FcγRIIa Polymorphism
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Evaluation of ORR Stratified by FcγRIIIa Polymorphism
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29444231Jurczak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MOR00208 (formerly Xmab 5574) in people with Non-Hodgkin Lymphoma, run by MorphoSys AG at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy, United States, Poland, Germany, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From first dose until Follow-up Visit 12, up to 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.