NCT06220201进行中（未招募）1 期
A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company86 个研究点 分布在 6 个国家目标入组 120 人开始时间: 2024年3月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 86
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Relapsing forms of Multiple Sclerosis (RMS) - Cohort
- •i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.
- •ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.
- •- Progressive forms of MS - Cohort
- •i) Participants must have an EDSS ≥ 3.0 and ≤ 6.
- •ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).
- •- Myasthenia Gravis - Cohort 3
- •i)MGFA classification of II-IV at screening
- •ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening)
- •iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.
- •iv) Has had thymectomy, only if indicated according to current guidelines.
排除标准
- •Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in <240 seconds unless extenuating medical conditions unrelated to MS prohibit this.
- •Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
- •Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Administration of CC-97540 (PMS arm)
Experimental
干预措施: Cyclophosphamide (Drug)
Administration of CC-97540 (PMS arm)
Experimental
干预措施: Fludarabine (Drug)
Administration of CC-97540 (RMS arm)
Experimental
干预措施: Fludarabine (Drug)
Administration of CC-97540 (RMS arm)
Experimental
干预措施: Cyclophosphamide (Drug)
Administration of CC-97540 (RMS arm)
Experimental
干预措施: CC-97540 (Drug)
Administration of CC-97540 (PMS arm)
Experimental
干预措施: CC-97540 (Drug)
Administration of CC-97540 (MG arm)
Experimental
干预措施: CC-97540 (Drug)
Administration of CC-97540 (MG arm)
Experimental
干预措施: Fludarabine (Drug)
Administration of CC-97540 (MG arm)
Experimental
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to week 104
Number of participants with serious adverse events (SAEs)
时间窗: Up to week 104
Number of participants with laboratory test result abnormalities
时间窗: Up to week 104
Number of participants with adverse events of special interest (AESIs)
时间窗: Up to week 104
Number of participants with imaging abnormalities
时间窗: Up to week 104
For Cohorts 1 and 2
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Up to week 104
Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
时间窗: Up to week 104
次要结局
- Annualized relapse rate(Up to week 104)
- Number of participants meeting no evidence of disease activity (NEDA) criteria(Up to week 104)
- Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)(Up to week 12)
- Change from baseline in magnetic resonance imaging (MRI) metrics(Up to week 104)
- Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))(Up to week 104)
- Number of participants with disability improvement confirmed per EDSS(Up to week 12)
- Maximum observed blood concentration (Cmax)(Up to week 104)
- Time of maximum observed blood concentration (Tmax)(Up to week 104)
- Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast)(Up to week 104)
- Number of participants with at least 2 points improvement for at least 4 weeks in Myasthenia Gravis activities of daily living (MG-ADL) score(Up to week 26)
- Number of participants with at least 3 point improvement in Myasthenia Gravis composite (MG-C) score(Up to week 26)
- Number of participants with at least 3 point improvement in quantitative Myasthenia Gravis (QMG) score(Up to week 26)
研究者
研究点 (86)
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