EUCTR2020-002985-15-GB进行中（未招募）1 期
A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE
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
- 22
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. Subjects = 18 to = 80 years (at date of signing the informed consent form [ICF]).
- •2. Urine protein to creatinine ratio (UPCR) of = 3.0 g/g (as determined by a 24 h urine collection) or proteinuria = 3.5 g/24 h (as determined by a 24 h urine collection)
- •3. Anti-PLA2R antibody positive MN in need for IST according to the investigator’s judgment. 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 to screening is acceptable.
- •4. Estimated glomerular filtration rate (eGFR) = 50 ml/min/1.73 m².
- •Alternatively, subjects with an eGFR >30 and < 50 ml/min/1.73 m² can be included provided an interstitial fibrosis and tubular atrophy (IFTA) score of < 25% in a kidney biopsy is histologically documented; for this purpose, a biopsy at screening or an archival biopsy acquired within 6 months prior to start of screening is needed.
- •5. Not in spontaneous remission despite proper treatment with angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines.
- •6. Systolic blood pressure (BP) = 150 mmHg and diastolic BP = 100 mmHg after 5 minutes of rest.
- •7. Serum anti-PLA2R antibodies = 50.0 RU/mL determined by Euroimmun ELISA.
- •8. Female subjects: A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a. Not a female of childbearing potential (FCBP) ; OR
- •b. A FCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of MOR202.
- •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 for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Hemoglobin < 80 g/L (4.9 mmol/L).
- •2. Thrombocytopenia: Platelets < 100.0 x 10^9/L.
- •3. Neutropenia: Neutrophils < 1.5 x 10^9/L.
- •4. Leukopenia: Leukocytes < 3.0 x 10^9/L.
- •5. B-cells < 5 x 10^6/L
- •6. Secondary cause of MN (e.g. malignancies, medications, systemic lupus erythematosus).
- •7. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, immunoglobulin A (IgA) nephropathy).
- •8. Diabetes mellitus type 1.
- •9. 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 diabetes is controlled, as shown by:
- •a. Glycated hemoglobin (HbA1c) <8.0 % or 64 mmol/mol.
- •b. No diabetic retinopathy known.
- •c. No peripheral neuropathy known.
- •10. Previous treatment with an anti-CD38 antibody.
- •11. Prior to screening start, oral or parenteral treatment with:
- •a. Mycophenolate mofetil (MMF) or high dose corticosteroids (> 20 mg prednisone/day) within 30 days prior to start of screening.
- •b. Alkylating agents (e.g. cyclophosphamide) or calcineurin inhibitors (CNIs) (e.g. tacrolimus, cyclosporine A) within 90 days.
- •c. Biologic drugs including rituximab (RTX) within 180 days.
- •d. Any other oral/parenteral IST within 180 days.
- •12. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator.
- •13. Clinically relevant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening.
- •14. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity = grade 3.
- •15. Total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.
- •16. Known or suspected hypersensitivity to MOR202 and its excipients (L-histidine, sucrose, polysorbate 20).
- •17. 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 enroll).
- •18. For any other preexisting symptoms and impairments of health or any residual toxicity from prior therapy classified = grade 3 (NCI-CTCAE): these subjects may be included upon confirmation by the Medical Monitor.
- •19. Any malignancy within 5 years prior to screening start, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non melanomatous skin cancer.
- •20. Treatment within 5 terminal half-lives (if known) or within the last 30 days prior to baseline (whatever is longer) with investigational drugs.
- •21. Any active infection (viral, fungal, bacterial) requiring systemic therapy.
- •22. Any other disease which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the trial.
研究者
相似试验
进行中（未招募）
1 期
Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)EUCTR2020-002985-15-GRHuman Immunology Biosciences, Inc.22
进行中（未招募）
1 期
Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)EUCTR2020-002985-15-DEMorphoSys AG22
已完成
2 期
Open Label Study to Evaluate tanibirumab (TTAC-001) in Patients with Recurrent GlioblastomaGlioblastomaACTRN12615001156572PharmAbcine Inc.12
已完成
不适用
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma-C82 Follicular lymphoma-C83 Non-follicular lymphoma-C85 Other and unspecified types of non-Hodgkin lymphomaNon-follicular lymphomaOther and unspecified types of non-Hodgkin lymphomaC82C83C85Follicular lymphomaPER-166-08PharmaMar,
进行中（未招募）
1 期
Phase 2 Study of Zandelisib in Subjects with Follicular Lymphoma or MarginalZone LymphomaFollicular lymphoma (FL) or Marginal Zone Lymphoma (MZL)MedDRA version: 21.0Level: LLTClassification code 10029473Term: Nodular (follicular) lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-002896-17-GBMEI Pharma, Inc.200