jRCT2013240076招募中不适用
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) (CYTB323I12201)
Novartis Pharma. K.K.0 个研究点目标入组 11 人开始时间: 2025年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Men and women, aged >=18 and =< 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 (ACR/EULAR 2022) classification criteria
- •Positive test for ANCA-autoantibodies
- •GPA and MPA participants with severe active disease
排除标准
- •Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study
- •Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol
- •Other systemic autoimmune diseases requiring therapy
- •Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy
- •Inadequate organ function
结局指标
主要结局
-
Event-free survival
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
2 期
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)Lupus Erythematosus, SystemicLupus NephritisNCT06581198Novartis Pharmaceuticals179
进行中（未招募）
2 期
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPAANCA Associated Vasculitis (AAV)NCT06868290Novartis Pharmaceuticals126
招募中
2 期
A clinical trial to learn about the effects of YTB323 in people with difficult-to-treat severe inflammatory myopathies (IIM)Severe refractory idiopathic inflammatory myopathies (IIM)2024-514137-38-00Novartis Pharma AG43
进行中（未招募）
2 期
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic SclerosisScleroderma, DiffuseNCT06655896Novartis Pharmaceuticals96
进行中（未招募）
2 期
Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHLFollicular Lymphoma Grade 3BMediastinal B-Cell Diffuse Large Cell LymphomaLymphoma, Large B-Cell, DiffuseHigh-grade B-cell LymphomaNCT06093841Shanghai Ming Ju Biotechnology Co., Ltd.46