2024-512891-37-00招募中2 期
A controlled phase II clinical trial evaluating the safety and efficacy of myelin peptide-loaded tolDC as treatment for Multiple Sclerosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Efficacy will be determined by evaluating the number of new and enlarging T2 lesions on MRI scans
研究概览
简要总结
Conduct a phase II clinical trial to assess the efficacy and safety of administrating myelin-derived peptide-pulsed tolDC, generated using Good Manufacturing Practice (GMP), in patients with Relapsing Remitting and Progressive MS.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •MS according to most recent Mc Donald’s diagnostic criteria
- •Ability to comply with the protocol assessments
- •Appropriate venous access
- •Use of adequate contraceptive measures during the duration of the trial. Women and men of reproductive potential can only be included in the study following use of adequate contraceptive measures. Accepted methods of contraception include use of hormonal contraceptives (oral, intravaginal, intrauterine, or transdermal), intrauterine devices, sterilization or postmenopausal status, use of condoms with spermicide
- •Age 18-60 years
- •Expanded disability status scale (EDSS) of 0-6.0 inclusive
- •Active MS (relapsing and progressive): 1 relapse in the past year and/or at least 1 enhancing lesion on brain MRI in the past year and/or at least 1 new or enlarging T2 lesion in comparison with a reference scan from maximum 1 year before
- •MS patients on first-line treatment (control arm) or untreated patients (no wish to be treated with currently available disease-modifying treatments or presence of treatment- related side effects; intervention arms)
- •No evidence of relapse in the month prior to start of screening and throughout the screening phase
- •Normal total lymphocyte count
- •Normal peripheral B cell count
- •Able to sign informed consent
排除标准
- •Previous use of severe immunosuppressive or cytostatic treatment, including cyclophosphamide, mitoxantrone, bone marrow transplantation or (hematopoietic or mesenchymal) stem cell transplantation (at any time) prior to enrolment
- •Fertile patients, both men and women, who are not using an adequate method of contraception. If the patient is menopausal or sterile, it must be documented in the medical history
- •Drug or alcohol abuse
- •Inability to undergo MRI assessments
- •History of or actual signs of immunodeficiency or malignancies
- •History of oncological diseases unless local basal cell carcinoma
- •Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease
- •Hepatitis B or C, HIV serology, syphilis or tuberculosis
- •Splenectomy
- •Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol
- •Participating in another interventional clinical trial, assessing an IMP, or having participated in one, in the last 6 months
- •Previous use of cladribine with last course within last 2 years or alemtuzumab with last course within last 4 years; lymphocyte counts should be above 800/mm3
- •Previous treatment in the phase I clinical trial with tolDC
- •Use of interferon beta and glatiramer acetate in the 4 previous weeks; use of teriflunomide in the previous 4 weeks with accelerated elimination procedure; use of dimethyl/diroximel fumarate in the previous 4 weeks with normal lymphocyte counts (above 800/mm3)
- •Treatment with fingolimod, siponimod, ponesimod, ozanimod, natalizumab, immunoglobulins or plasmapheresis in the past 3 months; teriflunomide in the previous 15 weeks without accelerated elimination; anti-CD20 monoclonal antibody (including ofatumumab, rituximab and ocrelizumab) within the past 6 months prior to the first administration and until confirmation of B cell count normalization; for S1P modulators lymphocyte counts should be above 800/mm3
- •Use of another investigational product in the past 6 months or longer depending on the mode of action
- •Previous use of azathioprine or methotrexate in the past 3 months
- •Previous use of other immunosuppressive agents washout is at least 3 months or longer depending on the mode of action and half-life
- •Relapse / use of corticosteroids for any reason in the previous month
- •Pregnancy or planning pregnancy in the next 18 months and breast feeding;
结局指标
主要结局
Efficacy will be determined by evaluating the number of new and enlarging T2 lesions on MRI scans
Efficacy will be determined by evaluating the number of new and enlarging T2 lesions on MRI scans
次要结局
- The number and severity of adverse events
- Proportion of relapse-free patients
- Changes in relapse rate (compared with the year before inclusions)
- Changes from baseline in mean EDDS scores and supplementary ambulatory clinical outcome measures
- change from baseline in T1 Gd and T2 lesion load, atrophy, and total brain volume on MRI scans
研究者
Amber Dams
Scientific
Antwerp University Hospital
研究点 (2)
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