NCT03070327进行中（未招募）1 期
A Phase I Trial of B-cell Maturation Antigen (BCMA) Targeted EGFRt/BCMA-41BBz Chimeric Antigen Receptor (CAR) Modified T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma (MM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- MTD of gene-modified T cells
研究概览
简要总结
The purpose of this phase I clinical trial is to test the safety of these CAR T cells in patients with myeloma.
There are two parts of this study. Part 1 of the study consists of screening for BCMA, Lenalidomide assignment and cell collection. Part 2 of the study is treatment with modified CAR T cells.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed MM by MSKCC pathologist, with MM cells expressing BCMA, previously treated with 2+ prior lines of therapy including an IMiD and a PI, either with refractory, persistent, or progressive disease
- •Age ≥ 18 years of age
- •Creatinine ≤2.0 mg/dL, direct bilirubin ≤2.0 mg/dL, AST and ALT ≤3.0x upper limit of normal (ULN)
- •Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
- •HGB≥7g/dl, ANC≥1,000/mm3, Platelet≥30,000/mm3 without transfusion or growth factor support for at least 1 week
- •M spike ≥0.5 g/dL or involved free light chain ≥10 mg/dL with an abnormal free light chain ratio
排除标准
- •Karnofsky performance status <70
- •Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
- •Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan
- •Patients with following cardiac conditions will be excluded:
- •New York Heart Association (NYHA) stage III or IV congestive heart failure
- •Myocardial infarction ≤6 months prior to enrollment
- •History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- •History of severe non-ischemic cardiomyopathy
- •Patients with HIV or active hepatitis B or hepatitis C infection are ineligible
- •Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin
- •Patients with a prior allogeneic transplant ARE eligible UNLESS previously or currently experienced GvHD that required systemic steroids or other systemic lymphotoxic therapy
- •Patients on systemic steroids (except if solely for adrenal replacement) within two weeks of collection
- •Active auto-immune disease including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy
- •Prior treatment with gene modified T cells
- •Prior or active CNS involvement by myeloma (eg leptomeningial disease). Screening for this, for example, by lumbar puncture, is only required if suspicious symptoms or radiographic findings are present
- •Plasma cell leukemia
- •Pre-existing (active or severe) neurologic disorders (e.g. pre-existing seizure disorder)
- •Active uncontrolled acute infections
- •Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study
- •Patients who previously had any intolerance to Lenalidomide 10 mg or who have a contraindication to Lenalidomide will not be eligibile for concominant treatment with Lenalidomide but will remain eligible for CAR T cell therapy without Lenalidomide.
研究组 & 干预措施
BCMA Targeted CAR T Cells with or without Lenalidomide
Experimental
干预措施: EGFRt/BCMA-41BBz CAR T cell (Biological)
BCMA Targeted CAR T Cells with or without Lenalidomide
Experimental
干预措施: Cyclophosphamide (Drug)
BCMA Targeted CAR T Cells with or without Lenalidomide
Experimental
干预措施: Lenalidomide. (Drug)
结局指标
主要结局
MTD of gene-modified T cells
时间窗: 36 months
The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. T cell dose may be divided in up to three infusions administered over up to 7 days.
次要结局
未报告次要终点
研究者
研究点 (1)
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