NCT04626908Unknown1 期
Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma
He Huang1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma
详细描述
This is a single-arm, single-center, open clinical study to evaluate the safety and efficacy of GC022F injection in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
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
- •Male or female, 18-75 years old (including the threshold value);
- •Histologically confirmed as diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), or primary mediastinal B-cell lymphoma (PMBCL) :
- •i. Refractory B-NHL: PD was the optimal response to standard first-line treatment (those with intolerance to first-line treatment were not included in this study); Or SD after at least 4 courses of first-line treatment, and the DURATION of SD shall not exceed 6 months after the last treatment; Or the subjects' best response to the last treatment of second-line or above treatment is PD, or SD after at least 2 courses of second-line or above treatment, and the SD maintenance time is not more than 6 months; Or:
- •ii. Relapsed B-NHL: after standard systemic treatment and complete remission after second-line treatment, the disease recurred as certified by histopathology, or the recurrence as confirmed by histopathology within 1 year after autologous hematopoietic stem cell transplantation (not limited by previous treatment methods);
- •iii. Patients with INVERt follicular lymphoma must receive chemotherapy prior to transformation and meet the above definition of recurrent or refractory after transformation;
- •according to Lugano treatment response standard (2014 version), there should be at least one evaluable tumor lesion: the longest diameter of the injunctional lesion was > 1.5cm, and the longest diameter of the injunctional lesion was b> 1.0cm;
- •Positive expression of CD19 and CD22 in biopsy sections of tumor tissues;
- •Patients who have failed or relapsed after single-target CAR-T therapy may also be enrolled.
- •Prior to the study, the approved anti-B-NHL treatment, such as systemic chemotherapy, general radiotherapy and immunotherapy, has been completed for at least 2 weeks;
- •Expected survival ≥3 months;
- •Absolute count of neutrophils ≥ 1×109/L;
- •Platelet count ≥50×109/L;
- •Absolute lymphocyte count ≥1×108/L;
- •Adequate organ function reserve:
- •ALANINE aminotransferase and aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
- •Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
- •Serum total bilirubin ≤1.5× UNL;
- •The left ventricular ejection fraction (LVEF) of the subject was diagnosed by echocardiography ≥50%, and no clinically significant pericardial effusion was observed, and no clinically significant ecg abnormalities were observed;
- •under natural indoor air environment, the basic oxygen saturation of > is 92%;
- •Vein access required for collection can be established, and there are no contraindications for leukocyte collection;
- •Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion; male subjects with fertile partners must agree to use effective barrier contraceptive method at least one year after infusion and avoid sperm donation;
- •Voluntary signing of informed consent.
排除标准
- •Other tumors (except cured non melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast ductal carcinoma in situ, or other malignant tumors with complete remission for more than 5 years);
- •Persons with severe mental disorders;
- •A history of hereditary diseases such as Fanconi anemia, Schrader syndrome, Costerman syndrome, or any other known bone marrow failure syndrome;
- •A history of allogeneic stem cell transplantation;
- •Heart disease with grade III-IV heart failure [New York Heart Association (NYHA) classification] or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically significant cardiac conditions within the year prior to enrollment;
- •The presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, bile drainage tube or pleural/peritoneal/pericardial catheter), allowing the use of a dedicated central venous catheter;
- •Subjects with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastasis;
- •A history or disease of the central nervous system, such as seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
- •The results of any of the following virology-ELISA tests were positive: HIV antibody, HCV antibody, TPPA, hepatitis B surface antigen;
- •There were active infections requiring systematic treatment within 2 weeks before single collection;
- •Persons with a known severe allergic reaction to cyclophosphamide or fludarabine, or with an allergic constitution;
- •A history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has caused injury to the terminal organs or requires systemic immunosuppressive/disease-modulating drugs within the past 2 years;
- •Pulmonary fibrosis is present;
- •Has received treatment in another clinical trial within 4 weeks prior to participation in this trial, or the date of signing of the informed consent is within 5 half-lives (whichever is longer) of the last medication used in the last other clinical trial;
- •Poor compliance due to physiological, family, social, geographical and other factors, unable to comply with the research program and follow-up plan;
- •The presence of a comorbiditie requiring systemic corticosteroid therapy (≥5 mg/ day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive agents within 6 months of study treatment was determined by the investigator;
- •Lactating women who do not want to stop breastfeeding;
- •Any other condition that the researcher considers inappropriate to be included in the study.
研究组 & 干预措施
Administration of GC022F CAR-T cells
Experimental
Each subject receive GC022F CAR T-cells by intravenous infusion
干预措施: GC022F CAR-T cells (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Within 28 days after cell infusion
Proportion of patients with dose limiting toxicity (DLT) after cell infusion
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: 24 months after cell infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- Overall response rate(ORR)(Month 1,3,6,12,18and 24)
- Overall survival (OS)(Month 6,12,18and 24)
- Progression-free survival (PFS)(Month 6,12,18and 24)
- Duration of response(DOR)(Month 6,12,18and 24)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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