NCT04026100Unknown1 期
A Phase I Clinical Trial of CTA101 UCART Cells Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity（DLT）
研究概览
简要总结
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of CTA101 in relapsed or refractory diffuse large B-cell lymphoma 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed diagnosis of DLBCL per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL and PMBCL transformed from follicular lymphoma;
- •Relapsed or refractory DLBCL (meeting one of the following conditions):
- •Recurrence, progression or stable disease (SD) after treatment with second-line or above second-line chemotherapy regimens;
- •Recurrence or progression after autologous hematopoietic stem cell transplantation;
- •At least one measurable lesion must be ≥ 1.5cm in the longest diameter;
- •Male or female aged 18-70 years;
- •Estimated survival time ≥ 12 weeks;
- •Serum albumin ≥ 30g/L, total bilirubin ≤ 25.7umol/L, creatinine ≤ 132.6umol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) <3 times of upper limit of normal;
- •Absolute neutrophil count ≥ 1.0*10^9/L, platelet count ≥ 50*10^9/L;
- •ECOG performance status 0 to 1;
- •Echocardiographic diagnosis shows left ventricular ejection fraction (LVEF) ≥ 50%;
- •No active infection in the lungs;
- •Latest treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatment) must have been completed at least 2 weeks prior to screening;
- •All women of child-bearing potential must have a negative blood or urine pregnancy test at screening, and agree to take medically acceptable contraception measures while on study treatment;
- •Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
排除标准
- •History of hypersensitivity to any component of cell product;
- •Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
- •Recurrence after allogeneic hematopoietic stem cell transplantation;
- •Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis), or currently receiving antibiotic therapy by intravenous drip. However, prophylactic antibiotic, antiviral and antifungal treatments are allowed;
- •HBV DNA copy number detected by PCR in patients with active hepatitis B is > 1000 at screening (if HBsAg positive, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection;
- •Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1);
- •Patients with Corrected QT interval(QTc)>450 msecs (Fridericia formula);
- •Patients with a history of epilepsy;
- •Intracranial extranodal lesions (tumor cells in cerebrospinal fluid, and/or MRI shows intracranial lymphoma invasion);
- •Extensive invasions of gastrointestinal lymphoma (lesions involving the muscular layer, serosa and subserosa, excluding lesions confined to the mucosa and submucosa);
- •History of other primary cancer, except for the following conditions:
- •Cured non-melanoma after resection, such as basal cell carcinoma of the skin
- •Cured carcinoma in situ, such as cervical cancer, bladder cancer or breast cancer
- •Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;
- •Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;
- •Women pregnant or lactating, with a pregnancy plan within 6 months, fertile but unable to take medically acceptable contraception measures;
- •Patients who have participated in any other clinical studies within 2 weeks prior to screening;
- •Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
结局指标
主要结局
Dose-limiting toxicity（DLT）
时间窗: Baseline up to 35 days after T cell infusion
Adverse events assessed according to NCI-CTCAE v4.03 criteria
次要结局
- Overall response rate (ORR)(4 weeks, 12 weeks, 6 months, 12 months, 18 months and 24 months)
- Disease control rate (DCR)(12 weeks, 6 months, 12 months, 18 months and 24 months)
研究者
研究点 (1)
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