NCT04056975Unknown1 期
A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
EVIVE Biotechnology0 个研究点目标入组 54 人开始时间: 2019年9月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 54
- 主要终点
- Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
研究概览
简要总结
Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
详细描述
Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell 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
- •18-75 years, all genders
- •Patients with definite B-cell Lymphoma, includes FL, MZL, MCL, DLBCL.
- •Patients With Relapsed or Refractory B-cell Lymphoma
- •Lesions are measurable in 21 days before treatment
- •Normal bone marrow function
- •Normal liver, kidney, lung and heart function
- •the Subjects can sign the ICF and obey the protocol, elsewise, his/her guardian should sign
- •Life expectancy is at least 3 months
排除标准
- •Past or present CNS disease
- •Associated with lymphoma by the infiltrates of CNS
- •A history of autoimmune disease with CNS involvement or autoimmune disease
- •Previous history of autoimmune disease or other malignancy
- •A history of deep venous thrombosis or pulmonary embolism
- •Auto-HSCT was performed within 12 weeks prior to initiation of treatment
- •Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
- •The Investigator determined that the patients were associated with a disease, medical condition, or social factor that might affect study results or compliance
- •Immunosuppressant are being used
- •Radiotherapy was given within 6 weeks prior to A-319 treatment
- •Chemotherapy, immunotherapy and targeted therapy were received within 4 weeks before A-319 treatment
- •Previous CAR-T cell therapy
- •Received anti-lymphoma drugs in the first 4 weeks of A-319 treatment
- •There was no recovery of toxic effects (CTCAE> grade 1 adverse events) at the last treatment, except hair loss
- •Those who underwent major surgery 28 days before enrollment (excluding lymph node biopsy);Or plan to operate during the study period
- •Those who had received active/attenuated live vaccine within 28 days prior to screening
- •For pregnant (positive pregnancy test) and lactating women, those of childbearing age who signed the informed consent form and did not agree to use contraception for at least 3 months after the end of the study;Within 7 days prior to the first day of treatment, women of childbearing age require a positive serum pregnancy test (HCG)
- •Male patients who signed informed consent forms and did not agree to use contraception for at least 3 months at the end of the study (except surgical sterilization)
- •Known allergy to immunoglobulin or research drugs and their excipients
- •Patients considered unfit to participate in the study
结局指标
主要结局
Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Incidence and Characteristics of SAE
Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
时间窗: At the end of Cycle 1 (each cycle is 28 days)
dose limited toxicity(DLT), maximum tolerance dose(MTD)
次要结局
- Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma(At the end of Cycle3 (each cycle is 28 days))
- Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma(At the end of Cycle3 (each cycle is 28 days))
- Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma(At the end of Cycle3 (each cycle is 28 days))
- Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma(At the end of Cycle3 (each cycle is 28 days))
- Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma(At the end of Cycle3 (each cycle is 28 days))
- Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma(At the end of Cycle3 (each cycle is 28 days))
- Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma(At the end of Cycle3 (each cycle is 28 days))
研究者
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