QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies

Zhejiang University1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2021年11月4日最近更新: 2022年5月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 24
试验地点: 1
主要终点: The incidence of subjects with Dose Limiting Toxicities within each dose level cohort

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma.

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL. Up to 22-36 patients will be enrolled.

详细描述

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 24-36 patients will be enrolled.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of B-cell lymphoma or B-ALL as described below:
•B-cell Lymphoma:
•Histologically documented lymphomas expected to express CD19 and CD20
•Relapsed/refractory disease following at least two prior systemic treatment regimens, or relapsed after the autologous hematopoietic stem cell transplantation (HSCT)
•Diagnosis of B-ALL that expected to express CD19
•Relapsed/refractory disease following prior systemic treatment regimens
•ALL SUBJECTS:
•Provision of signed and dated informed consent form (ICF)
•Age ≥ 18 years old
•Stated willingness to comply with study procedures and duration
•Eastern Cooperative Oncology Group (ECOG) performance status ≤1
•Adequate organ function as defined in the protocol
•Donor specific antibody (DSA) to QN-019a: MFI <= 2000
•At least 3 weeks after the last systemic immunochemotherapy treatment
•The estimated survival days are expected to be over 3 months

排除标准

•ALL SUBJECTS:
•Females who are pregnant or lactating
•Evidence of insufficient organ function as defined in the protocol
•ECOG Performance Status ≥2
•Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T/CAR-NK within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
•Currently receiving or likely to require systemic immunosuppressive therapy
•Known active central nervous system (CNS) involvement by malignancy. Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease
•Clinically significant cardiovascular disease as defined in the protocol
•Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
•Donor specific antibody (DSA) to QN-019a: MFI > 2000
•Other comorbid conditions and concomitant medications prohibited as per study protocol
•Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject