NCT07152223撤回不适用
A Single-center Clinical Study to Evaluate the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
Guangzhou Bio-gene Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of Safety
研究概览
简要总结
This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good compliance: The patient or their guardian understands and voluntarily signs the informed consent form, and it is expected that all documents, procedures, follow-up examinations and treatments stipulated in the study can be completed.
- •Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria :
- •Systemic lupus erythematosus (SLE);
- •Rheumatoid arthritis (RA);
- •Systemic scleroderma (SSc) ;
- •Sjogren's Syndrome (SS);
- •Polymyositis/dermatomyositis (PM/DM);
- •Mixed connective tissue disease (MCTD).
- •Researchers determine that the disease is in an active stage;
- •At least one autoantibody is positive in the serum or plasma during the screening period;
- •Insufficient response, intolerance or recurrence to at least one standard treatment;
- •The pregnancy test of the female subjects was negative, and the subjects agreed to take effective contraceptive measures throughout the trial period.
- •The patient's major tissues and organs are functioning well.
排除标准
- •Intracranial hypertension or confusion;
- •Symptomatic heart failure or severe arrhythmia;
- •Respiratory failure;
- •Accompanied by other types of malignant tumors;
- •Diffuse vascular coagulation;
- •Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
- •Sepsis or other difficult-to-control infections;
- •Uncontrollable diabetes;
- •Severe mental disorder;
- •Cranial magnetic resonance imaging (MRI) examination revealed obvious lesions in the intracranial cavity.
- •WHO physical status classification ≥ level 3;
- •Organ transplant recipients;
- •Pregnant and lactating women;
- •HIV+，HBV，HCV，EBV，CMV.
研究组 & 干预措施
CAR-T
Experimental
The dosage range of 1.0 × 10^6/kg (± 20%) to 3.0 × 10^6/kg (± 20%) of CAR-T cells, administered intravenously.
干预措施: CAR-T (Biological)
结局指标
主要结局
Evaluation of Safety
时间窗: Up to 2 years after CAR-T infusion
Count the Incidence of adverse events
次要结局
- Effectiveness evaluation(Up to 2 years after CAR-T infusion)
- Pharmacokinetic parameters(Up to 2 years after CAR-T infusion)
- Pharmacodynamic parameters(Up to 2 years after CAR-T infusion)
研究者
研究点 (1)
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