NCT05673447招募中早期 1 期
An Exploratory Clinical Study of Safety and Efficacy of Anti-CD19 CAR NK Cells in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicity (DLTs)
研究概览
简要总结
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells in patients with B-cell Non Hodgkin Lymphoma. 9-12 patients are planned to be enrolled in the dose-escalation trial (6×10^8 cells, 1×10^9 cells, 1.5×10^9 cells). The primary endpoints are DLT, MTD. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR).
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
- •Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
- •Clinical diagnosis of CD19 positive diffuse large B cell lymphoma as defined by the 2017 World Health Organization (WHO) classification of tumors of haematopoietic and lymphoid tissue.
- •Relapsed/Refractory diffuse large B cell lymphoma refers to: not complete response (CR) of 2 lines of standard treatment; PD after treatment or duration of SD less than 6 months after treatment; progress or relapse within 12 months after autologous stem cell transplant.
- •Subjects with a measurable or evaluable lesion (more than one lesion≥15mm) according to IWG criteria.
- •Age≥ 18 years old and ≤ 75 years old, male or female.
- •Subjects with estimated survival > 12 weeks.
- •Serum albumin (ALB) ≥30g/L, Total Bilirubin (TBIL) ≤ 25.7μmol/L, serum creatinine (SCr) ≤ 132.6μmol/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN).
- •Absolute neutrophil count (ANC) ≥ 1.0×109/L, platelet count ≥ 50×109/L.
- •ECOG performance ≤
- •Left ventricular ejection fraction (LVEF) ≥50% and no clinically significant pericardial effusion.
- •≥ 4 weeks after subjects received last dose treatment (Radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments).
排除标准
- •Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions.
- •Relapsed after allogenic haemopoietic stem cell transplantation (HSCT).
- •Subjects with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior to anti-CD19 CAR NK Cell infusion.
- •Subjects with acquired and congenital immunodeficiency diseases.
- •Subjects with grade III or IV heart failure (NYHA classification).
- •History of epilepsy or other central nervous system (CNS) diseases.
- •Subjects with extranodal lymphoma in Intracranial, lung, or gastrointestinal tract.
- •History of other primary malignant tumors except:
- •Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC);
- •Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer.
- •Systemic corticosteroids are used concomitantly within 2 weeks prior to treatment.
- •Females who are pregnant, lactating, or planning a pregnancy within six months.
- •Subjects who have received other clinical trial treatment within 3 months.
- •Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.
结局指标
主要结局
Incidence of dose limiting toxicity (DLTs)
时间窗: within 4 weeks after infusion
To characterize the safety, tolerability, and determine the Maximum tolerated dose (MTD) of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma.
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: up to 48 weeks after infusion
To characterize the safety of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma
次要结局
- The overall response rate (ORR)(1, 3, 6 and 12 months after infusion)
- Disease control rate (DCR)(1, 3, 6, 12 and 12 months after infusion)
研究者
研究点 (1)
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