NCT01645293Unknown1 期
Multicentre Phase I Trial of Engineered T Cells for Patients With Relapsed or Refractory Primary Cutaneous CD30+ Large T Cell Lymphoma or Transformed CD30+ Mycosis Fungoides
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
研究概览
简要总结
Patients with cutaneous CD30 positive lymphoma will receive systemical and topical treatment with their own genetically modified T cells. Treatment evaluation consists of assessment of safety and preliminary evidence of response.
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written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.
- •* Male or female \> 18 years of age to 70 years of age
- •* Diagnosis of primary cutaneous CD30+ large T cell lymphoma OR
- •* Diagnosis of transformed CD30+ mycosis fungoides, i.e.,
- •* Histological confirmation of diagnosis.
- •* multiple (\> 5) cutaneous tumor lesions (TNM EORTC 2007 T3, N1, clinical stage \ 12 months
- •* Female patients with childbearing potential must have a negative serum pregnancy test within two weeks of first dose of study drug. Male and female patients must agree to use an effective oral contraceptive method while on study treatment, if appropriate, and for a minimum of twelve months following study therapy
排除标准
- •Previously untreated patients
- •Presence of any organ or brain involvement as determined during tumor staging by contrast computed tomography [CT] or magnetic resonance imaging [MRI] scan
- •Known hereditary blood coagulation disorders/DIC
- •Prior allogeneic hematopoietic stem-cell or organ transplantation
- •Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency > NHYA-II
- •known active infection including HIV, Hepatitis B or C, VZV, or CMV
- •Insufficient bone marrow reserve (Leucocytes <3.500/μl; Thrombocytes <100.000/μl)
- •Creatinine-Clearance < 50 ml/min or Crea > 1.8 mg/dl
- •Bilirubin > 2 mg/dl; ASAT, ALAT > 2.5xN
- •Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- •Known pulmonary dysfunction
- •Requirement of chronic immune suppression
- •Treatment with corticosteroids for concomitant or intercurrent disease
- •Having participated in another clinical trial or any IND in the preceding 4 weeks
- •Anti-cancer chemotherapy in the preceding 4 weeks
- •Known drug abuse/alcohol abuse
- •Known allergic/hypersensitivity reaction to any of the components of the treatment
- •Known serious uncontrolled infections
- •Known active secondary malignancy or other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the skin or cervix
- •Medical or psychological condition or inadequate knowledge of german language which in the opinion of the investigator would not permit the patient to complete the study or meaningfully sign informed consent
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
Genetically modified T cells #1138
Experimental
干预措施: Genetically modified T cells # 1138 (Genetic)
结局指标
主要结局
Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
Definition of maximum tolerated dose (MTD) of engineered T cells #1138.
次要结局
- Preliminary evidence of response to treatment
研究者
Prof. Dr. med. Dr. rer. nat Cornelia Mauch
Consultant dermatologist, CIO tumor centre
University of Cologne
研究点 (1)
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