NCT04500431Unknown1 期
Clinical Study to Evaluate the Safety and Feasibility of Targeting CD269 Chimeric Antigen Receptor Engineered T Cell (spCART-269) Injection in the Treatment of CD269-positive Multiple Myeloma
Shanghai Tongji Hospital, Tongji University School of Medicine1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients.
详细描述
This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269. Subjects who meet the eligibility criteria will receive a single dose of spCART-269 injection. The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.
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
- •The patient was diagnosed as active MM according to the diagnostic criteria of the International Myeloma Working Group (IMWG)
- •The patient meets any of the following:
- •Have received at least 3 treatment options in the past and include alkylating agents, proteasome inhibitors and immunomodulators;
- •If the patient has received a regimen containing proteasome inhibitor and immunomodulator for at least 2 courses, and the effect is not good (such as disease progression within 60 days of treatment)
- •Voluntary participation in clinical research and signing informed consent
- •Age 18-65, regardless of gender
- •Expected survival time is greater than 12 weeks
- •If the patient has received autologous hematopoietic stem cell transplantation in the past, a 90-day interval is required
- •Normal bone marrow hematopoietic function, blood routine: hemoglobin ≥ 100 g/L; absolute neutrophil ≥ 1.5×10^9/L; platelet count ≥ 100×10^9/L
- •Liver function: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 (ULN) times the upper limit of normal value (if abnormal liver function is mainly caused by tumor infiltration, it can be ≤ 5 times the upper limit of normal value (ULN) )), bilirubin <2.0 mg/dL
- •Renal function: BUN is 9-20 mg/dL, serum creatinine ≤ 1.5 times the upper limit of normal (ULN), endogenous creatinine clearance rate ≥50 ml/min
- •Serum virus EBV, CMV, HBV, HCV, HIV and syphilis antibodies are negative
- •Heart function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 45%
- •ECOG physical status score 0-2
- •Possess apheresis or sufficient venous access for venous blood, and no other contraindications for leukocyte separation
- •T cells can be successfully expanded in vitro
- •Women of childbearing age who provide negative reports of pregnancy tests with serum or urine before reinfusion
- •Adults with fertility requirements, regardless of sex, contraception within one year after treatment
排除标准
- •ECOG score ≥ 3 points
- •Female patients during pregnancy or lactation
- •Pathological examination revealed malignant tumor cells with T cell origin
- •Organ failure: Heart failure grade Ⅲ and Ⅳ; liver reaches Child-Turcotte liver function grade C; renal failure and uremia; respiratory failure; consciousness disorder
- •Patients with acute or chronic GVHD after allogeneic hematopoietic transplantation, or using hormones or immunosuppressants within 30 days
- •Patients with HIV infection or active hepatitis
- •There are other uncontrolled active infections
- •Those who may be allergic to cytokines
- •Those who have used any gene therapy products
- •Those who participated in other clinical studies 4 weeks before enrollment (except those who did not receive treatment in clinical studies)
- •Patients with systemic autoimmune diseases or immunodeficiency diseases
- •Definite neuropathy or psychosis, including authors of dementia or epilepsy
- •Those with lung or intestinal tumor infiltration
- •Patients that other researchers think are not suitable for enrollment
结局指标
主要结局
Occurrence of study related adverse events
时间窗: 12 weeks
Incidence and severity of Treatment emergent adverse events
次要结局
- Overall response rate (ORR)(12 months)
- Overall survival (OS)(12 weeks, 6 months, 12 months)
- Duration of remission (DOR)(12 months)
- Progression free survival (PFS)(12 months)
研究者
Aibin Liang，MD，Ph.D.
Vice President of Tongji Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
研究点 (1)
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