Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- TEAEs
研究概览
简要总结
The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.
详细描述
CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.
- •Positive expression of specific antigens.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0~
- •Adequate organ functions:
- •Serum bilirubin ≤ 35 μmol/L;
- •Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2;
- •Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
- •Brain natriuretic peptide (BNP)<80 pg/mL.
- •Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
排除标准
- •History of allergy to any of the drugs involved in the protocol.
- •History of cardiac diseases:
- •Left ventricular ejection fraction (LVEF) < 50%;
- •Class III or IV heart failure as defined by the New York Heart Association (NYHA).
- •History of another malignancy tumor.
- •Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
- •Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
- •Uncontrolled fungal, bacterial, viral, or other infection.
- •Female subjects who are pregnant or lactating.
研究组 & 干预措施
Autologous CAR-T cells
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.
干预措施: Autologous CAR-T cells (Biological)
Autologous CAR-T cells
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.
干预措施: Fludarabine (Drug)
Autologous CAR-T cells
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
TEAEs
时间窗: 4 weeks
Incidence and severity of Treatment Emergent Adverse Event.
TRAEs
时间窗: 4 weeks
Incidence and severity of Treatment Related Adverse Events.
AESIs
时间窗: 4 weeks
Incidence and severity of AEs of Special Interest.
次要结局
- Objective Response Rate (ORR) (PR+CR)(12 months)
- Progression-Free Survival (PFS)(12 months)
- Overall survival (OS)(12 months)