NL-OMON49767撤回2 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 Anti-body Positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE - MOR202
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- MorphoSys AG
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. *18 to *80 years (at date of signing ICF)
- •2. Urine protein to creatinine ratio (UPCR) of * 3.0000 g/g OR proteinuria *
- •3.500 g/24 h from 24-hr urine at screening
- •3. Active and anti-PLA2R antibody positive MN in need for IST according to
- •investigator judgement and with diagnostic biopsy, archival biopsy
- •acquired within 5 years prior to screening is acceptable
- •4. Estimated glomerular filtration rate (eGFR) *50 ml/min/1.73m² or >30 and <50
- •ml/min/1.73m², and IFTA (interstitial fibrosis and tub-ular
- •atrophy) score of less than 25% on a renal biopsy obtained within the last 6
- •months prior to start of screening. If a subject falls into the latter
- •range without availability of an adequate biopsy, a biopsy at screening should
- •be performed for 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 of rest as measured at screening
- •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; interval to first dose of MOR202 must be at least 14days (1)).
- •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
- •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 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,
- 另有 2 项未显示
排除标准
- •1. Hemoglobin < 80 g/L
- •2. Thrombocytopenia: Platelets < 100.0x10^9/L
- •3. Neutropenia: Neutrophils < 1.5x10^9/L
- •4. Leukopenia: Leukocytes < 3.0x10^9/L
- •5. Hypogammaglobulinemia: Serum immunoglobulins *4.0 g/L
- •6. B-cells < 5 x 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 membranous nephropathy without histological signs of
- •diabetic nephropathy and their disease is controlled, such as:
- •o Hba1c <8.0 % or 64 mmol/mol,
- •o No diabetic retinopathy known
- •o 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 tox-icity * grade 3
- •16. Total bilirubin, aspartate aminotransferase and alanine aminotransferase
- •>1.5 x ULN, alkaline phosphatase >2.0 x 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, su-crose, 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 preexisting symptoms and impairments of health classified or
- •any re-sidual toxicity from prior therapy * grade 3 (NCICTCAE,
- •see 3.2): these subjects may be included upon confirmation by the medical
- •department of the sponsor
- •21. Pregnancy or breast feeding
- 另有 4 项未显示
研究者
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