NCT04304040进行中（未招募）1 期
A Phase I/IIa Study on Dose-escalation and Extension of Recombinant Humanized Type II CD20 Monoclonal Antibody MIL62 Injection Combined With BTK Inhibitor Orelabrutinib in the Treatment of Recurrent/Refractory CD20+B-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 10
- 主要终点
- Dose limiting toxicity (DLT)(Dose escalation phase)
研究概览
简要总结
Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, gender not limited
- •Dose escalation phase: Histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma; Expansion stage: R/R NHL Or histologically diagnosed CD20 positive chronic lymphocytic leukemia/small lymphocytic lymphoma;
- •Dose escalation phase ：Patients who have received at least one treatment regimen Expansion stage：Patients who have received at least one to four treatment regimens with at least one regimen containing rituximab;
- •Eastern cancer collaboration group(ECOG) physical status score: 0-2
- •Laboratory tests performed within 7 days prior to the first acceptance of the study drug met the protocol criteria.
- •Expected survival ≥6 months
- •Sign a written informed consent.
排除标准
- •Expansion stage: DLBCL transformed from follicular lymphoma, DLBCL with follicular lymphoma, and lymphomas with primary or central nervous system involvement.
- •Received any of the anti-tumor treatments(note in the protocol) before the first study drug.
- •Previous use of any anticancer vaccine.
- •Patients who had received hematopoietic stem cell transplantation within 3 months before the first administration
- •Patients scheduled for major surgery within 28 days prior to initial administration or during the expected study period.
- •Patients who Is participating in other clinical trials or first administration less than 28 days after the end of the previous clinical trial.
- •Receiving prednisone treatment or other corticosteroid treatment with the same dose as prednisone ;Patients who require warfarin or an equivalent vitamin K antagonist;
- •During the study period, drugs with moderate or severe inhibition or strong induction of cytochrome CYP3A4 were taken together;
- •Subject has a history of any of the diseases note in the protocol;
- •Patients with infections;
- •Impact testing scheme compliance or other serious results explain the poor control of the merger of the disease(note in the protocol);
- •Toxicity of any previous anticancer treatment has not recovered to ≤1, except for hair loss;
- •A history of severe allergic reactions to humanized monoclonal antibodies or known allergies to any component of Orelabrutinib or MIL62;
- •Inability to swallow research drugs, or the presence of conditions that significantly affect gastrointestinal function;
- •Hepatitis b surface antigen (HBsAg) and/or hepatitis b core antibody (HBcAb) are positive ; Hepatitis c virus (HCV) antibody positive and HCV RNA positive patients; Human immunodeficiency virus (HIV) serum response was positive;
- •Pregnant and lactating women; For women of childbearing age who have not undergone sterilization surgery: do not agree to use appropriate methods of contraception;
- •For men not undergoing sterilization: do not agree to use the barrier method of contraception;
- •Other circumstances considered inappropriate for the study by the investigator.
研究组 & 干预措施
Single Arm
Experimental
干预措施: Orelabrutinib (Drug)
Single Arm
Experimental
干预措施: Recombinant humanized monoclonal antibody MIL62 injection (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)(Dose escalation phase)
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Safety observation indicator
Maximum tolerated dose (MTD) (Dose escalation phase)
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Safety observation indicator
Recommended dose for phase 2 trials of two-drug combinations (RP2D) (Dose escalation phase)
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Safety observation indicator
objective remission rate(ORR) (Dose expansion phase)
时间窗: At the end of Cycle 30 (each cycle is 28 days)
Efficacy observation indicator
次要结局
- Duration of remission(DOR)(3 years after first treatment)
- objective remission rate(ORR)(At the end of Cycle 30 (each cycle is 28 days))
- Area under the plasma concentration vs time curve(AUC)(At the end of Cycle 6 (each cycle is 28 days))
- Apparent half-life for designated elimination phases (t½)(At the end of Cycle 6 (each cycle is 28 days))
- The peak plasma concentration (Cmax)(At the end of Cycle 6 (each cycle is 28 days))
- Progression-free survival(PFS) in the treatment of R/R CD20+B cell lymphoma(3 years after first treatment)
- overall survival(OS) in the treatment of R/R CD20+B cell lymphoma(3 years after first treatment)
- Duration of remission(DOR) in the treatment of R/R NHL(3 years after first treatment)
- Progression-free survival(PFS) in the treatment of R/R NHL(3 years after first treatment)
- overall survival(OS) in the treatment of R/R NHL(3 years after first treatment)
研究者
研究点 (10)
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