A Phase II/III Prospective, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed/ Refractory B-Acute Lymphoblastic Leukaemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia
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
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics
- •Age between ≥13 to ≤ 65 years
- •No detectable leukaemia in the CSF (CNS-1)
- •CNS leukaemia without clinically evident neurological symptoms (CNS-2; with <5 WBC per μL and cytology positive for blasts)
- •Adequate organ function as defined by a creatinine clearance > 50 ml/min, serum total bilirubin < 5 times the normal value, left ventricular ejection fraction > 40%
- •ECOG performance status ≤ 2
- •Life expectancy > 3 months
- •Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression
- •Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods
- •Male patients must use highly effective contraception methods
排除标准
- •Patients with CNS-3 leukaemia.
- •Active cancer (other than B-ALL).
- •Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder.
- •Presence of active autoimmune disease or atopic allergy.
- •HIV serology positivity.
- •Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.
- •Uncontrolled sepsis
- •Pregnant / nursing female.
- •Ongoing prednisolone > 1mg/kg daily or equivalent.
- •Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.
研究组 & 干预措施
CD19 CAR-T CELLS
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
干预措施: CD19 CAR-T CELLS (Biological)
CD19 CAR-T CELLS
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
干预措施: Cyclophosphamide (Drug)
CD19 CAR-T CELLS
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
干预措施: Fludarabine (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Participants will be followed for the duration of the treatment, with an expected average of 3 months.
Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria.
CR with incomplete blood recovery (CRi).
时间窗: 12 Months
Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.
Complete response (CR)
时间窗: 12 Months
Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.
次要结局
- Overall survival (OS)(12 Months, 24 Months)
- Progression free survival (PFS)(12 Months, 24 Months)
- Time to next treatment (TTNT)(12 Months, 24 Months)
- Percentage of adverse events(30 days)
研究者
Prof. Dr S Fadilah Abdul Wahid
Head of Pusat Terapi Sel / Principal Investigator
National University of Malaysia