NCT04034446终止早期 1 期
a Feasibility and Safety Study of Bispecific CD19-CD22 CAR-T Cell in the Treatment of Relapsed or Refractory B-ALL
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
详细描述
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with relapsed or refractory B-ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CD19-CD22 CAR-T cell infusion.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent is signed by a subject or his lineal relation.
- •Age 3 and older.
- •Documentation of cluster of differentiation 19 (CD19) and or cluster of differentiation 19 (CD22) expression on leukemic blasts in the BM, peripheral blood within 3 months of screening.;
- •Relapsed or refractory B-cell ALL
- •Relapse within 12 months of first remission
- •Without remission after 2 cycles of induction chemotherapy regimen.
- •Without remission or relapse after salvage treatments.
- •Any BM relapse after autologous stem cell transplantation (ASCT).
- •Without remission or relapse after any prior CD19 targeted therapy;
- •Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation Thr315Ile (T315I) mutation.
- •Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening；
- •Eastern cooperative oncology group (ECOG) performance status of 0 to
- •Adequate organ function defined as:
- •Aspartate aminotransferase (AST) ≤3 upper limit of normal (ULN);
- •Serum alanine aminotransferase (ALT) ≤3 ULN;
- •Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome;
- •Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible.
- •A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min（Cockcroft and Gault）
- •Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air.
- •Absolute lymphocyte count ≥0.3 x 10⁹/L.
- •Women of child-bearing potential and all male participants must use highly effective methods of contraception for a period of 1 year after the CD19-CD22 CAR-T cells infusion.
排除标准
- •Active central nervous system leukemia
- •Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
- •Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
- •Major surgery within ≤ 4 weeks before enrollment.
- •Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent.
- •Impaired cardiac function:
- •Left Ventricular Ejection Fraction (LVEF) ≤45%;
- •III/IV congestive heart failure (NYHA);
- •Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia);
- •Corrected QT interval (QTc) ≥450ms (male) or QTc≥470ms (female)（QTc using Bazett's formula (QTcB)=QT/RR^0.5）;
- •Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery.
- •Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
- •Patients with a history of epilepsy or other active central nervous system diseases.
- •Life expectancy < 12 weeks.
- •Allergy to macromolecule biopharmaceuticals such as antibodies or cytokines.
- •Subjects who are receiving systemic steroid treatment and who have been determined by the researchers to require long-term treatment with systemic steroids during treatment, and subjects treated with systemic steroids must be excluded < 72 hours prior to CNCT19 infusion (except inhalation or local use).
- •Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
研究组 & 干预措施
A
Experimental
Single dose of CD19-CD22 CAR-T cells
干预措施: CD19-CD22 CAR-T cells (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: 24 months
Overall remission rate (ORR)
时间窗: 3 months
次要结局
- Response at Day 28 days(1 month)
- Overall survival (OS)(24 months)
- Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment.(6 months)
- Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow(6 months)
- Relapse-free survival (RFS)(24 months)
- Duration of remission (DOR)(24 months)
研究者
研究点 (1)
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