ISRCTN17901467进行中（未招募）1 期
A pilot study: evaluation of efficacy and safety of autologous or graft HLA-matched donor-derived CD19 CAR-T cells for the treatment of CD19-positive recurrent and refractory B cell malignancies in adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult patients with CD19-positive recurrent and refractory B cell malignancies, aged 18-70 years old
- •2. Karnofsky Performance Status (KPS) score =60, expected survival =3 months
- •3. Platelet count (PLT) =30 × 10^9/L
- •4. Lymphocyte count (LYM) =0.15 × 10^9/L
- •5. Serum alanine aminotransferase (ALT) =100 U/mL
- •6. Total bilirubin (T-BIL) =30 µmol/L
- •7. Creatinine =200 µmol/L
- •8. Women of childbearing age are negative for the urine pregnancy test before the start of dosing and agree to take effective contraceptive measures
- •9. Voluntary participation, good compliance: willing to take part in studies and cooperate with clinical observations and follow-up plan
排除标准
- •1. Clinically diagnosed as central nervous system leukemia
- •2. Patients with hyperleukocytosis (WBC =50 × 10^9/L), or the researcher judges that the patient cannot receive a complete treatment cycle due to his rapid disease progress
- •3. Patients with fungi, bacteria, viruses or other uncontrolled infections or requiring isolation
- •4. Patients with positive HIV, HBV, and HCV
- •5. Patients with central nervous system diseases such as stroke, epilepsy, dementia or autoimmune neurological disorders
- •6. Patients with myocardial infection, cardiac angiography or stent, active angina or other obvious clinical symptoms, or with cardiac asthma or cardiovascular lymphocytic infiltration within 12 months prior to enrollment
- •7. Patients who are receiving anticoagulant therapy or who have severe coagulation disorders (aPTT >70)
- •8. Patients who receive medication that may affect the safety and efficacy of CAR-T cell product
- •9. Patients with a history of allergies to the biologics used in this project
- •10. Pregnant or lactating women
- •11. Patients who use systemic steroids within 2 weeks prior to treatment (except for inhaled steroids)
- •12. Patients with other uncontrolled diseases who are considered to be unsuitable to anticipate in the research by researchers
- •13. Any conditions that researchers believe may increase the risk to patient safety or may interfere with the overall outcome
研究者
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