NCT02640209终止1 期
Pilot Trial of Autologous T Cells Engineered to Express Anti-CD19 Chimeric Antigen Receptor (CART19) in Combination With Ibrutinib in Patients With Relapsed or Refractory CD19+ CLL or SLL
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Open-label pilot study to determine safety and efficacy of CART-19 cells in combination with ibrutinib. The target dose will be 1-5x10xE8 CART-19 transduced cells administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3. 15 evaluable subjects (adults) with relapsed or refractory CLL/SLL who have achieved partial response or stable disease on ibrutinib therapy will be eligible to receive CART-19 therapy.
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
- •Documented CD19+ CLL or SLL
- •Successful test expansion -cells (as described in Section 6.1)
- •Patients must have failed at least 1 prior regimen before Ibrutinib (not including single agent rituximab or single agent corticosteroids)
- •a. Note: Any relapse after prior autologous SCT will make the patient eligible regardless of other prior therapy.
- •Patients must be currently receiving ibrutinib for at least 6 months prior to enrollment in the study and:
- •Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
- •The best response to ibrutinib therapy must not have exceeded partial response or stable disease (i.e. no CR or CRi)
- •Note: Patients carrying a deletion at chromosome 17p (i.e. del[17p]), and/or TP53, BTK, and at the PLCγ2 loci mutations, will be eligible if they are receiving frontline therapy with ibrutinib.
- •ECOG Performance status 0 or 1
- •18 years of age and older
- •Adequate organ system function including:
- •Creatinine < 1.6 mg/dl
- •ALT/AST < 3x upper limit of normal
- •Total Bilirubin <2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.
- •Patients with relapsed disease after prior allogeneic SCT (myeloablative or nonmyeloablative) will be eligible if they meet all other inclusion criteria and:
- •Have no active GVHD and require no immunosuppression
- •Are more than 6 months from transplant
- •No contraindications for leukapheresis
- •Left Ventricular Ejection fraction >40%
- •Gives voluntary informed consent
- •Subjects of reproductive potential must agree to use acceptable birth control methods.
排除标准
- •CLL patients with known or suspected transformed disease (i.e. Richter's transformation). Note: biopsy proven absence of transformation is not required.
- •Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- •Uncontrolled active infection.
- •Active hepatitis B or hepatitis C infection.
- •Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •HIV infection.
- •Patients with active CNS involvement with malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment.
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- •Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment.
- •Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
研究组 & 干预措施
Arm 1
Experimental
干预措施: CART 19 (Biological)
结局指标
主要结局
Number of Adverse Events
时间窗: 26 months
次要结局
未报告次要终点
研究者
研究点 (1)
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