2024-519511-33-00尚未招募2 期
A Phase IIa Trial Evaluating the Efficacy of anti-CD19 Chimeric Antigen Receptor Engineered T-Cells in Patients With Systemic Sclerosis (SSc) Resistant to Immunosuppressive Drugs. SCLEROCAR
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Improvement of disease activity assessed from baseline to month 6 after CAR T ANTI-CD19 cell administration through change of at least 5 points in the modified Rodnan Skin Score (mRSS).
研究概览
简要总结
To evaluate the clinical efficacy of the CAR T ANTI-CD19 cell therapy on skin fibrosis assessed by mRSS score month 6 after CAR T ANTI-CD19 cell administration in patients with systemic sclerosis resistant to immunosuppressive drugs.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of systemic sclerosis according to ACR/EULAR classification
- •Refractory corresponds to patients with active disease (as defined by EUSTAR ≥2.5) and to patients with a worsening disease despite 6 months of at least 2 immunosuppressive treatments including one DMARDs (methotrexate, azathioprine, mycophenolate mofetil), and one biological DMARD rituximab or tocilizumab.
- •Age: ≥18 ≤65 years old
- •Adequate organ functions assessed within 4 weeks of inclusion:
- •Adequate venous access for apheresis
- •Leucapheresis : a wash-out period of 6 weeks for conventional immunosuppressants (i.e. methotrexate, mycophenolate mofetil)
- •Leucapheresis : at least 3 months after biotherapy (i.e. tocilizumab, 6 months for rituximab),
排除标准
- •Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases
- •pregnant or breastfeeding women
- •patients with advanced cognitive disorders or any other cause preventing their informed consent
- •ECG showing prolonged QT interval or history of severe heart diseases or FEVG < 40%
- •Lung and / or heart severe dysfunction defined by CVF<50% and/or DLCO <40%
- •Pulmonary arterial hypertension defined by catheterism (mean AP > 25mmHg at rest or > 30mmHg after exercise, PAPO < 15mmHG)
- •Active infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 < 1 months
- •Active hematological or solid neoplasm
- •Methylprednisolone or prednisone (≤20 mg) instead of immunosuppressive agents
- •Rituximab within 6 months to leukapheresis
- •Live vaccines within 30 days prior to leukapheresis
结局指标
主要结局
Improvement of disease activity assessed from baseline to month 6 after CAR T ANTI-CD19 cell administration through change of at least 5 points in the modified Rodnan Skin Score (mRSS).
Improvement of disease activity assessed from baseline to month 6 after CAR T ANTI-CD19 cell administration through change of at least 5 points in the modified Rodnan Skin Score (mRSS).
次要结局
- Change in the EUSTAR activity index (EUSTAR AI)
- Change in mRSS
- Change in the lung capacity FVC (forced vital capacity) and DLCO
- Extension of fibrosis through pulmonary TDM
- Change in cardiac ejection fraction and global longitudinal strain
- Change in scleroderma-adapted Health Assessment Questionnaire (SHAQ) score.
- Change in Health Assessment Questionnaire Disability Index HAQ-DI score
- Incidence rate of adverse events
- Incidence rate of AE of special interest (AESI)
- Pharmacokinetic parameters linked to CART quantification (Tmax, Cmax, AUC), as well as the subpopulations of B and T immune cells,
研究者
Pr Christian Jorgensen
Scientific
Centre Hospitalier Universitaire De Montpellier
研究点 (3)
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