EUCTR2017-004958-42-SE进行中（未招募）1 期
A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- Female
入选标准
- •1. Able to understand and voluntarily provide written informed consent to participate in the study.
- •2. Female and =18 years of age.
- •3. Pregnant to an estimated GA of 8 up to 14 weeks.
- •4. A previous pregnancy with a gestation that included at least one of the following at =24 weeks gestation:
- •a. Severe fetal anemia, defined as hemoglobin =0.55 multiples of the median (MoM) for GA **refer to table on page 12 of the protocol.
- •b. Fetal hydrops (ascites) with an MCA-PSV MoM =1.5
- •c. Stillbirth with fetal or placental pathology indicative of HDFN
- •5. Maternal alloantibody titers for anti-D of =32, or anti-Kell titers =4.
- •6. Free fetal deoxyribonucleic acid (DNA) consistent with an antigen positive fetus (blood sample drawn from the mother).
- •7. Maternal evidence for immunity to measles mumps, rubella, and varicella, as documented by serologies performed during Screening. If initial serologies are borderline
- •or negative, they may be repeated at a second lab. Alternatively, vaccination records can
- •be used to support evidence of immunity.
- •8. Screening IgG and albumin levels within the laboratory normal ranges.
- •9. Willing to receive standard of care with IUT if clinically indicated.
- •10. Agree to receive recommended vaccinations per local standard of care for both mother and child throughout the course of the study.
- •11. Willing to forego collection of cord blood for stem cell storage or other non-study purposes.
- •12. For mother and neonate, willing to forego participation in another clinical trial of an investigational therapy for the duration of their participation in the current study.
- •13. Willing to consent to a 24-week safety follow-up period for the patient and a 96-week safety follow-up period for the neonate/infant.
- •14. It is recommended that patients are up-to-date on age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study patients who received locally-approved (and including emergency use-authorized) COVID-19 vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standards of care for pregnant women receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrollment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Currently pregnant with multiples (twins or more).
- •2. Pre-eclampsia in current pregnancy or history of pre-eclampsia in a previous pregnancy.
- •3. Gestational hypertension in the current pregnancy
- •4. Current unstable hypertension
- •5. History of severe or recurrent pyelonephritis; or 4 or more lower urinary tract infections in the past year or in a previous pregnancy
- •6. History of genital herpes infection
- •7. History of atypical mycobacterial disease or herpes zoster infection within the last 6 months.
- •8. History of malignancy (except treated basal cell carcinoma of the skin) with or without systemic cancer chemotherapy.
- •9. Positive for HIV, hepatitis B, or hepatitis C during Screening.
- •10. Presence of any of the following during Screening: clinically significant abnormal hematologic laboratory values, creatinine >1.5 X upper limit normal (ULN), or clinically significant abnormal ECG reflective of heart disease.
- •11. Active infection at Screening or Baseline with Coxsackie, syphilis, cytomegalovirus, toxoplasmosis or herpes simplex 1 or 2, as evidenced by clinical signs and symptoms (evidence for prior infection or exposure, but without clinical signs and symptoms of active infection is acceptable).
- •12. Active infection with tuberculosis as evidenced by positive QuantiFERON-TB testing.
- •13. Immunosuppression because of underlying medical condition, including:
- •History of hereditary or congenital immunodeficiencies, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia
- •History of solid organ or bone marrow transplantation
- •Any prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease that may jeopardize the safety of the subject, require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results.
- •14. Requires treatment with corticosteroids or immunosuppression for disorders unrelated to the pregnancy (use of low-potency topical corticosteroids or intra-articular corticosteroids is permitted).
- •15. History of drug allergy, hypersensitivity, or intolerance to any drug product that, in the opinion of the Investigator, would compromise the safety of the patient.
- •16. In the Investigator’s opinion, shows evidence of ongoing alcohol/substance abuse/dependence.
- •17. Smoking during pregnancy.
- •18. Received plasmapheresis and/or IVIG during the current pregnancy for treatment of HDFN.
- •19. Has received or is expected to receive any live virus or bacterial vaccine within 12 weeks prior to screening or has a known need to receive a live vaccine while receiving nipocalimab, or within 12 weeks after the last administration of nipocalimab in the study or has received Bacille Calmett-Guérin (BCG) vaccine within 1 year prior to the first administration of nipocalimab
- •20. Currently receiving an antibody-based drug or an Fc-fusion protein drug
- •21. Received an investigational drug and/or device within 30 days or 5 half-lives prior to receiving the first IV infusion of nipocalimab.
- •22. Received nipocalimab in a prior clinical trial
- •23. A history or presence of clinically significant cardiovascular, pulmonary, hepatic (eg, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), renal, hematologic, gastrointestinal, endocrine/metabolic, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or severe or recurrent infections (eg, frequent hospitalized pneu
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