Safety and Efficacy Evaluation of IM19 Chimeric Antigen Receptor-modified T Cells (IM19CAR-T) In CD19+ B Cell Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies.
详细描述
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies(including B-cell Acute lymphoblastic Leukemia、B-cell Chronic Lymphocytic Leukemia、Non-Hodgkin's lymphoma) and Determine the Best Dosage.
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
- 4 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD19 positive relapsed or refractory B-cell malignancies, including B-cell Acute Lymphocytic Leukemia(ALL)、B-cell Chronic Lymphocytic Leukemia(CLL)、Non-Hodgkin's lymphoma(NHL).
- •Patients with ALL:
- •Previously treated with at least two courses of chemotherapy Ⅱ The interval of the last chemotherapy and disease progression is less than one year.
- •Ⅲ Not suitable for allogeneic stem cell transplantation. 2)Patients with CLL:
- •Previously treated with at least two courses of chemotherapy
- •Ⅱ The interval of the last chemotherapy and disease progression is less than two years.
- •Ⅲ Not suitable for allogeneic stem cell transplantation conditions or due to conditions to abandon allogeneic stem cell transplantation.
- •Patients with DLBCL or FL、PMBCL:
- •Patients who relapsed or were refractory after at least two previous treatments.
- •Ⅱ Patients who relapsed after transplantation. 4)Patients who have relapsed or have refractory mantle cell lymphoma after at least one treatment.
- •2.Measurable disease,including minimal residual disease. 3.Gender is not limited, to be aged 4 to 75 years 4.Expected survival >3 months. 5.Eastern Cooperative Oncology Group(ECOG) score 0-
- •6.Women of childbearing potential must have a blood pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
- •7.Absence of symptoms of central nervous system(CNS) leukemia.
排除标准
- •Patients who have been treated with chemotherapy or radiotherapy within 2 weeks before blood collection.
- •Patients have GVHD, which needs treatment with immunosuppressive agents,or patients with autoimmune diseases.
- •Patient who have been treated with systemic steroid medication within two weeks of blood collection（Except for the recent or current use of inhaled steroids）.
- •Patient who have been treated with stimulation of bone marrow hematopoietic cells generated drugs(Such as Recombinant Human Granulocyte Colony-stimulating Factor Injection) within 2 weeks before the blood collection period to use .
- •The number of T cells in peripheral blood is lower than 2×10^8/L.
- •Previously treatment with any gene therapy products.
- •History of epilepsy or other CNS disease.
- •New York Heart Association(NYHA) grade≥Ⅲ.
- •Creatinine> 1.5×normal value，Alanine transaminase(ALT) /Aspartate aminotransferase(AST)>3×normal value，Bilirubin >2×normal value.
- •Degree of myeloproliferation： Ⅳ-V
- •Active hepatitis B , hepatitis C or HIV infection and cytomegalovirus infection ,Epstein-Barr virus infection or any other uncontrolled active infection.
- •Pregnancy or breast-feeding women.
- •Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
- •Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
研究组 & 干预措施
IM19 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
干预措施: IM19 CAR-T (Biological)
IM19 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
干预措施: Fludarabine (Drug)
IM19 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Occurrence of study related adverse events
时间窗: 2 years
defined as \>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
次要结局
- Overall response rate(2 years)