NCT07072169招募中1 期
A Clinical Study to Investigate Safety, Tolerability, and Preliminary Efficacy of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Adult Patients With Relapsed or Refractory B-NHL
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of mRNA encoding CD19/CD3 T cell engager (ABO2203) in adult patients with relapsed or refractory CD19-positive B-NHL, This study included dose escalation and dose expansion parts.
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
- •≥18 years and ≤75 years of age at time of informed consent
- •Participants with histologically and/or cytologically confirmed relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma
- •With at least one of evaluable/measurable target lesions per Lugano 2014 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- •Life expectancy of ≥3 months
- •Sufficient organ function
排除标准
- •Central nervous system lymphoma
- •Previously undergone allogeneic hematopoietic stem cell transplantation or other organ transplants
- •Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or carcinoma in situ of the cervix
- •History of active autoimmune diseases
- •History of interstitial lung disease, tuberculosis, or other diseases that affect pulmonary function in the past or currently
- •Uncontrolled disease, including but not limited to uncontrolled diabetes, hypertension, active infections, active peptic ulcers, thromboembolic disease requiring anticoagulation, etc.
- •Severe cardiovascular diseases
- •History of severe allergies to protein-based drugs or any component of the study drug
研究组 & 干预措施
A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B
Experimental
ABO2203
干预措施: ABO2203 Injection (Drug)
结局指标
主要结局
A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL)
时间窗: From the first dose to 30 days after the last dose of ABO2203 treatment
The incidence and severity of adverse events evaluated by Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune DiseasesAutoimmune DiseasesNCT06747156Ruijin Hospital66
已完成
1 期
A Study of CL-197 Capsules in Healthy ParticipantsHIV-1NCT05944848HeNan Sincere Biotech Co., Ltd44
已完成
1 期
A Single Dose Escalation Trial of HRS-2129 in Healthy SubjectsPainNCT06619392Shandong Suncadia Medicine Co., Ltd.44
Unknown
1 期
A Study to Evaluate the Safety and Efficacy of Docetaxel for Injection (Albumin-bound)in Different Dose Regimens in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05114915CSPC ZhongQi Pharmaceutical Technology Co., Ltd.144
已完成
1 期
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy AdultsHealthyNCT01050127Abbott36