EUCTR2019-000780-24-PL进行中（未招募）1 期
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MorphoSys AG
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. =18 to =80 years, at date of signing informed consent form (ICF).
- •2. Urine protein to creatinine ratio (UPCR) of = 3.0000 g/g OR proteinuria = 3.500g/24 h from 24-h urine at screening.
- •3. Anti-PLA2R antibody positive MN in need for IST according to investigator's judgement. The diagnosis of MN should be histologically documented with a diagnostic biopsy; for this purpose, a biopsy at screening or an archival biopsy acquired within 5 years prior screening is acceptable.
- •4.Estimated glomerular filtration rate (eGFR) = 50 mL/min/1.73m². Alternatively eGFR =30 and <50 mL/min/1.73m² and interstitial fibrosis and tubular atrophy (IFTA) score < 25% in a renal biopsy obtained within the last 6 months prior to start of screening (if not available, a biopsy should be performed at screening to obtain the IFTA assessment).
- •5. Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and guidelines. If the PI determines that a subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained from the Medical Monitor prior to enrolment.
- •6. Systolic BP = 150 mmHg and diastolic BP = 100 mmHg after a period of 5 minutes rest.
- •7. Subject vaccinated against Pneumococcus within the last 5 years prior to date of signing ICF (subjects may be vaccinated during screening to meet this criterion during screening; interval to first dose of MOR202 must be at least 14 days [MSD SmPC]).
- •8. Cohort 1 comprises newly or relapsed subjects: Serum anti-PLA2R antibodies =50.0 RU/ml determined by Euroimmun ELISA at central laboratory.
- •9. 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 =20RU/mL measured at screening by the Euroimmun ELISA at central laboratory
- •10. Female of non-childbearing potential fulfilling one of the criteria:
- •a. post-menopausal: after 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms)
- •b. surgically sterile: tubal ligation at least 6 weeks before taking trial treatment, hysterectomy, or bilateral oophorectomy
- •c. genetically sterile: e. g. Turner syndrome, uterine agenesis.
- •11. Sexually active females of reproductive potential should use one of the following contraception options until 3 months after the last dose of MOR202:
- •a. One method of contraception that has a typical use failure rate of <1% (i.e., less than 1 pregnancy expected per 100 women), which would include
- •sterilization surgery for women, sterilization implant for women, sterilization surgery for men, Copper intra-uterine device (IUD), IUD with progestin, or implantable rod
- •b. A hormonal method of contraception (i.e., shot/injection, oral contraceptive, contraceptive patch, vaginal contraceptive ring, having typical use failure rate = 9%) plus a barrier method (i.e., diaphragm with spermicide, sponge with spermicide, cervical cap with spermicide, male condom, female condom, spermicide alone).
- •Note: France will only enroll patients in Cohort 2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects
排除标准
- •1.Hemoglobin < 80 g/L
- •2.Thrombocytopenia: Platelets < 100.0 × 109/L
- •3.Neutropenia: Neutrophils < 1.5 × 109/L
- •4.Leukopenia: Leukocytes < 3.0 × 109/L
- •5.Hypogammaglobulinemia defined as serum immunoglobulin = 4.0 g/L
- •6.B-cells < 5 × 106/L.
- •7.Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by the investigator.
- •8.Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).
- •9.Diabetes mellitus type 1.
- •10.Diabetes mellitus type 2: Subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows MN without evidence of diabetic nephropathy and their disease is controlled, such as:
- •Hba1c < 8.0 % or 64 mmol/mol
- •No diabetic retinopathy known
- •No peripheral neuropathy known
- •11.Previous treatment with an anti-CD38 antibody.
- •12.Subject received treatment with:
- •a.Mycophenolate mofetil (MMF) or high dose corticosteroids (> 20 mg prednisone/day), within 30 days prior to screening OR
- •b.Alkylating agents (e.g. cyclophosphamide [CYC]) or CNIs (e.g. tacrolimus, cyclosporine A [CSA]) within 90 days OR
- •c.Biologic drugs including RTX within 180 days
- •d.Any other oral/parenteral IST within 180 days.
- •13.Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator.
- •14.Clinically relevant findings on a 12-lead ECG as determined by the investigator at screening.
- •15.History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity = grade 3.
- •16.Total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × ULN, alkaline phosphatase (ALP) > 2.0×ULN.
- •17.Treatment within five terminal half-lives (if known) or within the last 30 days prior to baseline (whatever is longer) with investigational drugs.
- •18.Known or suspected hypersensitivity to MOR202 and its excipients (L-histidine, sucrose, polysorbate 20).
- •19.Serologic or virologic markers positive for HIV, hepatitis C (subjects with positive anti hepatitis C virus [anti-HCV] antibody but negative HCV RNA polymerase chain reaction [PCR] may enroll) or active or latent hepatitis B (subjects with positive hepatitis B surface antigen [HBsAg] are excluded, subjects with isolated positive hepatitis B core antibody [anti-HBc] but non-detectable hepatitis B virus (HBV) DNA by PCR may be enrolled).
- •20.For any other pre-existing symptoms and impairments of health classified or any residual toxicity from prior therapy = grade 3 (NCI-CTCAE, see Section 3.2): these subjects may be included upon confirmation by the medical department of the sponsor.
- •21.Pregnancy or breast feeding.
- •22.Any active infection (viral, fungal, bacterial) requiring systemic therapy.
- •23.Any malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
研究者
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