NCT06430671已完成1 期
Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients With Relapsing Remitting Multiple Sclerosis - RED4MS Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Cellerys AG
- 入组人数
- 11
- 试验地点
- 16
- 主要终点
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311]
研究概览
简要总结
RED4MS is a clinical trial to assess the safety and tolerability of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.
详细描述
The RED4MS trial is designed as an open-label, dose-escalation phase Ib study, enrolling 9 RRMS patients in three ascending dose groups. The first patient (sentinel) in each dose group will receive one cycle of the therapy, while the remaining patients will receive two treatment cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RRMS according to the 2017 McDonald criteria
- •Male or female patients (assigned at birth) aged 18-55 years inclusive
- •Disease duration (since diagnosis) <10 years
- •Expanded Disability Status Scale (EDSS) at baseline 0-5.5
- •Untreated patients or patients being off therapy for the time-periods listed under exclusion criterion No.
- •Patients are either not eligible to receive approved therapies or have explicitly chosen not to receive such therapies after being adequately informed by the investigators
- •Only for female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a highly effective method of contraception throughout the treatment phase or at least for 4 weeks after the last dose of the study drug
- •Male patients willing to use contraception (such as a condoms) throughout the treatment phase or at least for 4 weeks after the last dose of the study drug, unless surgically steril
排除标准
- •Patients with an active chronic disease (or stable but treated with immunomodulatory/-suppressive therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency)
- •Prior treatment with any of the medications specified in the protocol
- •History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B or Syphilis
- •Long-Covid19 syndrome
- •History of splenectomy or chronic liver disease
- •History of coronary artery disease, chronic heart failure, aortic stenosis
- •Current anticoagulation therapy
- •Uncontrolled grade II hypertension (≥160 systolic and/or ≥100 diastolic blood pressure according to the International Society of Hypertension (ISH) guidelines) despite treatment or without treatment
- •History of stroke
- •Pregnant female confirmed by a positive pregnancy test or breast-feeding
- •History of alcohol or drug abuse within the 1 year prior to screening visit 1
- •History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ
- •History of or existing relevant central nervous system disorder (other than MS)
- •Allergy to gadolinium-based contrast agents
- •Any other disease or condition, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.
- •Anemia, defined as hemoglobin levels ≤12.5 g/dl (7.25 mmol/l) for female and ≤13.5 g/dl (8.37 mmol/l) for male participants (may be repeated if 11.5-12.5 g/dl in females and 12.5-13.5 g/dl in males)
- •Erythrocyte count <4.0 E12/L in female and <4.5 E12/L in male patients (may be repeated if >3.8 E12/L in female and >4.3 E12/L in male)
- •Lymphopenia with total lymphocyte counts ≤1000/µl (may be repeated if >800/µl)
- •Positive HIV testing
- •Positive results of baseline period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection
- •Patient is not eligible for blood donation according to local regulations
- •Having one or more of the following laboratory results:
- •Estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73 m2 (may be repeated if eGFR 45-59 mL/min/1.73 m2)
- •ALT or AST >3x upper limit of normal (ULN; may be repeated if 3.1-4x ULN)
- •Total bilirubin greater than 2x ULN (may be repeated if 2.1-3x ULN), with the exception for patients with Gilbert's disease
- •Platelet count ≤100x109/L (may be repeated if 80-100x 109/L)
- •Abnormalities in hepatic synthetic function tests as judged by the Investigator to be clinically significant
研究组 & 干预措施
CLS12311 low
Experimental
Low dose CLS12311
干预措施: uncoupled RBCs (Drug)
CLS12311 low
Experimental
Low dose CLS12311
干预措施: CLS12311 low (Drug)
CLS12311 medium
Experimental
Medium dose CLS12311
干预措施: CLS12311 medium (Drug)
CLS12311 medium
Experimental
Medium dose CLS12311
干预措施: uncoupled RBCs (Drug)
CLS12311 high
Experimental
High dose CLS12311
干预措施: CLS12311 high (Drug)
结局指标
主要结局
Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311]
时间窗: on average 48 weeks
Number and severity of adverse events (AEs) and serious adverse events (SAEs) and worsening of disease measured by clinical (relapses) and imaging (number \& size of brain MRI lesions)
次要结局
- Incidence of patients experiencing worsening of SDMT in each dose group [Safety of CLS12311](on average 48 weeks)
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0 in each dose group [Safety of CLS12311](on average 48 weeks)
- Incidence of patients experiencing worsening of MS in each dose group [Safety of CLS12311](on average 48 weeks)
- Incidence of patients experiencing worsening of EDSS in each dose group [Safety of CLS12311](on average 48 weeks)
- Incidence of patients experiencing worsening of T25-FW in each dose group [Safety of CLS12311](on average 48 weeks)
- Incidence of patients experiencing worsening of 9-HPT in each dose group [Safety of CLS12311](on average 48 weeks)
研究者
研究点 (16)
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