antiPLA2R Positive, Glomerulonephritis, Membranous
Conditions
Brief summary
This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)
Detailed description
After treatment subjects will be observed for up to 1 year. Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Interventions
DRUGMOR202
Patients received 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occured weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Sponsors
HI-Bio, A Biogen Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The study is open label as all patients receive the same Investigational Medicinal Product (IMP) and same dose
Intervention model description
2 cohorts by disease status (Cohort 1: Patients with newly diagnosed or relapsed membranous nephropathy; Cohort 2: Patients with membranous nephropathy refractory to immunosuppressive treatment)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * \> 18 to \< 80 years (at date of signing informed consent form \[ICF\]). * Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h from 24-h urine at screening * Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable. * Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and \<50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening. * Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment. * Systolic blood pressure BP ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest * Vaccinated against Pneumococcus within the last 5 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days). * Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies ≥50.0 RU/mL * Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening Note: France will only enroll patients in Cohort 2. Key
Exclusion criteria
* Hemoglobin \< 80 g/L. * Thrombocytopenia: Platelets \< 100.0 x 109/L. * Neutropenia: Neutrophils \< 1.5 x 109/L. * Leukopenia: Leukocytes \< 3.0 x 109/L. * Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L. Subjects may receive supportive therapies to meet the above criteria * B-cells \< 5 x 106/L. * Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies) * Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Week 1 to Week 24 | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Percentage of Participants With Adverse Events | Week 1 to Week 24 | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | — |
| Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | — |
| Best Immunological Response Rate (BIRR) | Up to 52 weeks | The BIRR was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titer. |
| Number of Participants With AEs During the Follow-up Period | Week 25 to Week 52 | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Percentage of Participants With AEs During the Follow-up Period | Week 25 to Week 52 | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks) | — |
| Number of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | — |
Countries
Australia, Belgium, France, Italy, Netherlands, Poland, South Korea, Spain, United States
Participant flow
Pre-assignment details
A total of 65 participants were screened for this study. 31 participants were enrolled and received at least one dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. | 18 |
| Cohort 2 (Refractory Participants) Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. | 13 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Use of prohibited therapy | 2 | 3 |
Baseline characteristics
| Characteristic | Cohort 1 (Newly Diagnosed or Relapsed Participants) | Total | Cohort 2 (Refractory Participants) |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 11.34 | 57.5 years STANDARD_DEVIATION 11.81 | 55.0 years STANDARD_DEVIATION 12.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 24 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 13 Participants | 21 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 13 Participants | 24 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 13 | 0 / 18 | 0 / 13 |
| other Total, other adverse events | 15 / 18 | 12 / 13 | 8 / 18 | 5 / 13 |
| serious Total, serious adverse events | 2 / 18 | 3 / 13 | 1 / 18 | 1 / 13 |
Outcome results
Primary
Number of Participants With Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 1 to Week 24
Population: The Safety Analysis Set included all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Number of Participants With Adverse Events | 15 Participants |
| Cohort 2 (Refractory Participants) | Number of Participants With Adverse Events | 12 Participants |
Primary
Percentage of Participants With Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 1 to Week 24
Population: The Safety Analysis Set included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Percentage of Participants With Adverse Events | 83.3 percentage of participants |
| Cohort 2 (Refractory Participants) | Percentage of Participants With Adverse Events | 92.3 percentage of participants |
Secondary
Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Population: The IAS included all participants with at least one ADA result available. Here, the Overall Number of Participants Analyzed equals the number of participants with positive ADA titers and Number Analyzed is the number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline | 13.10 anti-felzartamab antibody titers |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies | Post First Dose (52 weeks) | 3.48 anti-felzartamab antibody titers |
| Cohort 2 (Refractory Participants) | Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline | 11.50 anti-felzartamab antibody titers |
Secondary
Best Immunological Response Rate (BIRR)
The BIRR was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titer.
Time frame: Up to 52 weeks
Population: The FAS included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Best Immunological Response Rate (BIRR) | 83.3 percentage of participants |
| Cohort 2 (Refractory Participants) | Best Immunological Response Rate (BIRR) | 61.5 percentage of participants |
Secondary
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Time frame: Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)
Population: The Pharmacokinetic Analysis Set (PKAS) included all participants with evaluable felzartamab serum concentration data. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and the Number Analyzed shows the number of participants evaluated at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | End of Study (up to week 52) | 278.0 nanogram(s)/millilitre (ng/mL) | — |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D8 | 89381.7 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 97.9 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D8 | 425669.4 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 50.7 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D15 | 174658.7 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 75.5 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D15 | 456390.9 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 70.6 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D22 | 185140.7 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 78 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D22 | 495612.5 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 57.3 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C2D1 | 24903.4 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 47.3 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C2D1 | 474157.9 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 108 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C3D1 | 34111.0 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 164.7 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C4D1 | 19811.2 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 218.1 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C5D1 | 27021.6 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 152 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C6D1 | 28734.6 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 116.9 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | End of Treatment (week 24) | 12367.0 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 349.9 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Follow-up visit (week 38) | 369.0 nanogram(s)/millilitre (ng/mL) | — |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D1 | 0.0 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D1 | 323499.3 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 98.3 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D1 | 0.0 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C4D1 | 30655.9 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 128.9 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D1 | 301417.5 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 151.9 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C2D1 | 148097.2 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 193.7 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D8 | 129924.9 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 100.7 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C6D1 | 30383.0 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 88.8 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D8 | 429629.4 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 91.7 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C2D1 | 415814.9 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 106.3 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D15 | 189047.7 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 80.9 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C5D1 | 35176.1 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 84.1 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D15 | 547940.5 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 60.2 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C3D1 | 25879.8 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 572.2 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Pre-dose C1D22 | 286607.9 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 25.7 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | End of Treatment (week 24) | 33813.6 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 61.9 |
| Cohort 2 (Refractory Participants) | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | Post-dose C1D22 | 656862.8 nanogram(s)/millilitre (ng/mL) | Geometric Coefficient of Variation 29.7 |
Secondary
Number of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Population: The Immunogenicity Analysis Set (IAS) included all participants with at least one antidrug antibody (ADA) result available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Number of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline | 1 Participants |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Number of Participants Tested Positive for Anti-felzartamab Antibodies | Post First Dose (52 weeks) | 1 Participants |
| Cohort 2 (Refractory Participants) | Number of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline | 1 Participants |
| Cohort 2 (Refractory Participants) | Number of Participants Tested Positive for Anti-felzartamab Antibodies | Post First Dose (52 weeks) | 0 Participants |
Secondary
Number of Participants With AEs During the Follow-up Period
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 25 to Week 52
Population: The Safety Analysis Set included all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Number of Participants With AEs During the Follow-up Period | 8 Participants |
| Cohort 2 (Refractory Participants) | Number of Participants With AEs During the Follow-up Period | 5 Participants |
Secondary
Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Population: The IAS included all participants with at least one ADA result available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Percentage of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline | 6.7 percentage of participants |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Percentage of Participants Tested Positive for Anti-felzartamab Antibodies | Post First Dose (52 weeks) | 6.7 percentage of participants |
| Cohort 2 (Refractory Participants) | Percentage of Participants Tested Positive for Anti-felzartamab Antibodies | Post First Dose (52 weeks) | 0.0 percentage of participants |
| Cohort 2 (Refractory Participants) | Percentage of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline | 7.7 percentage of participants |
Secondary
Percentage of Participants With AEs During the Follow-up Period
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 25 to Week 52
Population: The Safety Analysis Set included all participants who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) | Percentage of Participants With AEs During the Follow-up Period | 44.4 percentage of participants |
| Cohort 2 (Refractory Participants) | Percentage of Participants With AEs During the Follow-up Period | 38.5 percentage of participants |