NCT02277522终止早期 1 期
Pilot Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Linked to TCRζ and 4-1BB Signaling Domains in Patients With Chemotherapy Relapsed or Refractory Hodgkin Lymphoma
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as RNA CART19) in Hodgkin Lymphoma (HL) 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with HL with no available curative treatment options (such as autologous SCT) who have a limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
- •i. HL with biopsy-proven relapse or refractory disease who are unresponsive to or intolerant of at least one line of standard salvage therapy ii. Patients must have evaluable disease by radiologic imaging (FDG PET/CT or PET/MRI) within 42 days of enrollment; evaluable includes both assessable and/or measurable disease as defined by Cheson et al.,
- •Age ≥ 18 years of age
- •Creatinine < 1.6 mg/dl.
- •ALT/AST < 3x upper limit of normal
- •Bilirubin < 2.0 mg/dl, unless subject has Gilbert's syndrome (≤3.0 mg/dL)
- •Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) 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
- •Performance status (ECOG) 0 or
- •Left Ventricular Ejection Fraction (LVEF) ≥ 40% as confirmed by ECHO/MUGA
- •Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
- •Written informed consent is given.
- •Successful T cell test expansion (to be performed as part of inclusion criteria until 3 subjects meet all enrollment criteria)
排除标准
- •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 pregnancy test at enrollment. A urine or serum pregnancy test will be performed within 72 hours before the first RNA CART19 infusion.
- •Uncontrolled active infection.
- •Active hepatitis B or hepatitis C infection.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •HIV infection.
- •Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
- •Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment
- •Patients in complete remission with no evidence of evaluable disease by radiologic imaging.
- •History of allergy to murine proteins.
- •History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
- •Anti-CD20 monoclonal antibody therapy within the last 3 months, or absence of circulating B cells.
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
结局指标
主要结局
Number of Adverse Events
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
早期 1 期
CD123 Redirected Autologous T Cells for AMLRelapsed or Refractory Acute Myeloid LeukemiaNCT02623582University of Pennsylvania7
已完成
1 期
CART-BCMA Cells for Multiple MyelomaMultiple MyelomaNCT02546167University of Pennsylvania25
Unknown
不适用
Clinical Study of CAR-CLD18 T Cells in Patients With Advanced Gastric Adenocarcinoma and Pancreatic AdenocarcinomaAdvanced Gastric AdenocarcinomaPancreatic AdenocarcinomaNCT03159819Changhai Hospital24
Unknown
不适用
Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant TumorsB Cell LymphomaB Cell LeukemiaMyelomaPancreatic CarcinomaAdenocarcinoma of Esophagogastric JunctionHepatocellular CarcinomaNCT03302403Kang YU18
Unknown
1 期
Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple MyelomaRefractory or Relapsed Multiple MyelomaNCT03716856First Affiliated Hospital of Zhejiang University11