NCT05008536Unknown早期 1 期
Phase I Study to Evaluate the Safety and Effectiveness of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma
Xinqiao Hospital of Chongqing1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年10月1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
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicity (DLTs)
研究概览
简要总结
The purpose of this study is to infuse BCMA CAR-NK cells（Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells） to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •According to the international standard for multiple myeloma，have information on medical examination proving the diagnosis of multiple myeloma.
- •Received at least 2 prior lines of treatment, including proteasome inhibitor and immunomodulator, no efficacy more than PD; disease progression or relapsed after disease remission and refractory or no remission after treated in the last time.
- •Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level veing as defined ；or light chain MM without measurable disease in the serum or the urine；serum immunoglobulin free light chain isease dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio ；
- •ECOG Scores: 0~2（See Annex 3），the estimated survival time was more than 3 months;
- •During the screening period, the clinical laboratory values met the following criteria： Hemoglobins70g/L (did not receive red blood cell transfusion ≤7 days prior to laboratory tests，recombinant human erythropoietin is allowed); Platelet count >50×10^9/L (did not receive blood transfusion ≤7 days prior to laboratory tests); Neutrophil absolute count oietin is (did not receive supportive treatment lowed); Platelet count >50×10^9/L，allowed to use over growth factor support); ALT and AST ≤3×ULN；Total bilirubin ≤2.0× UNL；Creatinine clearance×40mL/min；corrected serum calcium L/minctordL (3.1 mmol/L), or free calcium ion or freedL(L( ommol/L); Prothrombin time and activated partial thromboplastin time ≤1.5×ULN.
- •The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation;
- •Females of childbearing potential and males must use efficient contraception（form signing the ICF to the end of the trial）
排除标准
- •Have received CAR-NK therapy；
- •Have a history of allergy to any component of cell products;
- •Previous history of other malignancy;
- •Any unstable cardiovascular disease happened the informed consent form by themselves or their legal guardian;boratory tests); be infused using the "3 + 3" dos grade), severe arrhythmia that require drug interference, cardiac angioplasty/coronary stent implantation/cardiac bypass surgery ≤6 months prior to enrollment;
- •Have received allogeneic hematopoietic stem cell transplantation in 3 months for the treatment of multiple myeloma;
- •who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- •There were live vaccinations within 4 weeks before admission;
- •Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
- •Oxygen is needed to maintain adequate oxygen saturation;
- •Contraindications for fludarabine or cyclophosphamide treatment.
- •There was uncontrolled active infection;Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive （excluding glucocorticoid）therapy;
- •Pregnant or breasting-feeding women;
- •Subjects had a history of alcohol, drug or mental illness;
- •Any other condition that researcher think it is inappropriate for the subject to anticipate the trial.
研究组 & 干预措施
Anti-BCMA CAR-NK Cells
Experimental
After preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated
干预措施: Anti-BCMA CAR-NK Cells (Biological)
Anti-BCMA CAR-NK Cells
Experimental
After preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated
干预措施: Fludarabine (Drug)
Anti-BCMA CAR-NK Cells
Experimental
After preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated
干预措施: Cytoxan (Drug)
结局指标
主要结局
Incidence of dose limiting toxicity (DLTs)
时间窗: within 2 monthes after infusion
To characterize the safety, tolerability of Anti-BCMA CAR-NK Cells
Overall Remission Rate (ORR)
时间窗: 2 monthes after infusion
Response assessment per International Myeloma Working Group (IMWG) criteria
次要结局
- Progression-free survival (PFS)(up to 24 months)
- Duration of Response (DOR)(up to 24 months)
研究者
Xi Zhang, MD
Chef of Hematology Department
Xinqiao Hospital of Chongqing
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MMMultiple MyelomaNCT03940833Asclepius Technology Company Group (Suzhou) Co., Ltd.20
招募中
1 期
An Early Clinical Study Evaluating the Safety and Efficacy of AcNK-Sup003 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's LymphomaB-cell Non-Hodgkin Lymphoma (B-NHL)NCT06693973Wuhan Union Hospital, China13
招募中
1 期
A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell MalignanciesNeoplasmsRelapsed Diffuse Large B-cell Lymphoma (DLBCL)Refractory Diffuse Large B-cell Lymphoma (DLBCL)Multiple Myeloma, RefractoryMultiple Myeloma in RelapseNCT05836896Technische Universität Dresden16
已完成
1 期
Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell TransplantationHematological MalignancyNCT01853358Institut Paoli-Calmettes17
进行中（未招募）
1 期
BCMA Targeted CAR T Cells With or Without Lenalidomide for the Treatment of Multiple MyelomaMultiple MyelomaNCT03070327Memorial Sloan Kettering Cancer Center20