2025-521145-24-01招募中2 期
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Idiopathic Inflammatory Myopathy or Active Juvenile Idiopathic Inflammatory Myopathy
Cabaletta Bio Inc.6 个研究点 分布在 3 个国家目标入组 13 人开始时间: 2026年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Incidence and severity of AEs
研究概览
简要总结
To evaluate adverse events reported by subjects
研究设计
- 分配方式
- Na
- 主要目的
- 1
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥6 to ≤75 years
- •A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria
- •Diagnosis of DM, ASyS, IMNM or JIIM based on the presence of serum myositis-specific antibodies
- •Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated 12 of 40 creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography
- •Presence of Muscle Weakness
排除标准
- •Contraindication to leukapheresis
- •History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
- •Active infection requiring medical intervention at screening
- •Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
- •Significant lung or cardiac impairment
- •Previous CAR T cell therapy
- •Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
- •Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
结局指标
主要结局
Incidence and severity of AEs
Incidence and severity of AEs
次要结局
- Incidence and severity of AEs, including changes in laboratory values and vital signs
- Levels of B cells in the blood
- Levels of CABA-201-positive T cells in the blood
- Levels of muscle enzymes (CK, LDH, AST, ALT, and aldolase) in serum
- Levels of autoantibodies from the Myositis-Specific Autoantibody Panel (e.g., MDA-5, Jo-1, and HMGCR) in the serum
- Total Improvement Score (0 to 100, with higher scores indicating greater improvement) based on the Core Set Measures
研究者
Cabaletta EU Regulatory
Scientific
Cabaletta Bio Inc.
研究点 (6)
Loading locations...
相似试验
招募中
2 期
A Phase I/II open label study to assess safety and preliminary evidence of a therapeutic effect of Azeliragon combined with conventional concurrent radiation and temozolomide in patients with newly diagnosed glioblastoma.Glioblastoma2024-512954-96-00Cantex Pharmaceuticals Inc.32
招募中
1 期
A Phase 1 Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAS-004, a MEK (1/2) Inhibitor, in Patients with MAPK Pathway-driven Advanced Solid Tumors with a Documented RAS, NF1, or RAF Mutation or Patients who have Failed BRAF/MEK Inhibition2024-510900-34-00Pasithea Therapeutics Corp.24
尚未招募
2 期
Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.NCT07391878Trigone Pharma Ltd.60
尚未招募
1 期
This is an Open-Label Study to Assess the Safety and Efficacy of GC012F in Patients With Multiple SclerosisMultiple SclerosisNCT07364487Huashan Hospital15
招募中
2 期
This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma2023-505347-38-00AbbVie Deutschland GmbH & Co. KG59