NCT06136364招募中1 期
Open-label, Dose-escalation Phase 1 Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory T-LBL/ALL
Hebei Senlang Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年8月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.
详细描述
Main research purposes:
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.
Secondary research purposes:
To preliminarily evaluate the efficacy, pharmacokinetics and pharmacodynamics of SENL101 in the treatment of patients with relapsed or refractory T-LBL/ALL.
Exploratory research purpose：
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects with refractory/relapsing T-LBL/ALL has been adequately treated and there is a lack of effective treatment, met one of the following criteria:
- •relapse: Primordial cells (>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears，include：
- •Early recurrence within 12 months，
- •Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy，
- •Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;
- •Refractory: patients who have received at least two courses standard induction regimen and failed to achieve a complete response or complete remission was not achieved after first-line or above salvage treatment;
- •The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening;
- •If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry.
- •Life expectancy greater than 12 weeks;
- •Age 18-75 (upper and lower limits included);
- •HGB at least 70g/L,PLT 50x109/L, can be transfused;
- •Liver and kidney functions The cardiopulmonary functions meet the following requirements:
- •Oxygen saturation under air ≥ 92%;
- •Total bilirubin <3×ULN;
- •ALT/AST<3×ULN;
- •Creatinine <1.5×ULN or creatinine clearance rate(Cockroft-Gault)>50ml/min;
- •Informed consent explained to, understood by and signed by patient/ guardian.
排除标准
- •Those who meet any of the following criteria are not eligible to join the group:
- •New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval >480ms at screening (QTc interval calculated by Fridericia formula);
- •If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;
- •Those with active GvHD or those who require immunosuppressive therapy;
- •Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;
- •History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)
- •Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);
- •History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating medication within the past 2 years;
- •When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded;
- •Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer);
- •History of severe allergy to biological products;
- •Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy;
- •Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion;
- •Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
- •Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.
结局指标
主要结局
Safety: Incidence and severity of adverse events
时间窗: 28 days after infusion
Incidence and severity of adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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