NCT03902197Unknown2 期
A Phase II Study of CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients Previously Treated With Cell Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Overall response rate (ORR) within 3 months
研究概览
简要总结
This Phase II study is to evaluate the efficacy and safety of a CD19-targeting humanized selective CAR-T (CD19 hsCAR-T) in refractory/relapsed CD19+ B-ALL leukemia patients who have no available curative treatment options, have a limited prognosis with currently available treatments, and were previously treated with a B cell directed cell therapy.
详细描述
CD19+ B-ALL patients who have relapsed after murine-based CD19 CAR-T (CD19mCAR-T) treatment and/or have limited clinical response to CD19mCAR-T will be enrolled to receive CD19 hsCAR-T treatment.
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with refractory/relapse B-cell ALL with no available curative treatment options (such as autologous or allogeneic SCT);
- •Subjects previously treated with B cell-directed engineered cell therapy are eligible if they meet the following criteria:
- •relapsed and/or MRD-positive after prior cell therapy;
- •partial response to prior cell therapy;
- •Clinical and laboratory data are available;
- •Documented CD19 expression after previous B cell-directed therapies;
- •Aged 1 to 75 years;
- •At least 2 weeks or 5 drug half-lives, whichever is shorter must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy;
- •Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and throughout the last follow-up visit;
- •Subjects with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if the patients do not present with active GVHD and are not undergoing immunosuppressive regimes;
- •Patients with CNS3 (WCB ≥5/mL in CSF with presence of lymphoblasts) disease will be eligible if the CNS disease is responsive to therapy;
- •Participation in the clinical trials should be voluntary with signed informed consent.
排除标准
- •Patients with hypervolemia (white blood cell count> 50 x 10^9 / L) or rapidly progressive disease that in the estimation of the investigators and sponsors would compromise the patient's ability to complete the study;
- •History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except for those with 3 years or longer of cure);
- •Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary);
- •Patients with positive results for HIV, HBV, HCV tests;
- •With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement;
- •History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac diseases within 12 months of enrollment, or with cardiac atrial or cardiac ventricular lymphoma;
- •Patients that are receiving anticoagulant therapy or have ever coagulation disorders;
- •Any medical condition that in the judgment of the sponsors/investigators is likely to interfere with assessment of safety or efficacy of study;
- •History of severe immediate hypersensitivity reaction to any of the agents used in this study;
- •Female patients who are pregnant or breastfeeding;
- •Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD28 co-stimulation;
- •Patients with any uncontrolled diseases that are unsuitable for enrollment;
- •CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity;
- •Any situation that is considered to potentially increase the risk of the subject or interfere with the outcome of the study;
- •Patients who have been enrolled in other clinical studies.
研究组 & 干预措施
CD19 hsCAR-T
Experimental
This cohort will be administrated by T cells transduced with lentivirus vectors expressing CD19 hsCAR
干预措施: CD19 hsCAR-T (Biological)
结局指标
主要结局
Overall response rate (ORR) within 3 months
时间窗: 3 months
Overall response rate (ORR) within 3 months after infusion of CD19 hsCAR-T
次要结局
- Best overall response (BOR)(3 months)
- Duration of remission (DoR)(1 year)
- Event free survival within 1 year(1 year)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])(6 months)
研究者
研究点 (2)
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