NCT05720052终止1 期
A Phase I/II Study to Evaluate the Safety and Efficacy of the MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma
MingSight Pharmaceuticals, Inc1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年2月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This is a Phase I/II, single-arm, multicenter, open-label study which is divided into two portions: Phase I is dose escalation portion, in which subjects with relapsed or refractory B-cell lymphoma will be enrolled except malignant lymphoblastic lymphoma (LBL) and Burkitt lymphoma. After the RP2D is identified, Phase II of subjects with relapsed or refractory mantle cell lymphoma who previously received ≥ 2 and ≤ 4 different chemotherapy and/or targeted drug therapy will be enrolled.
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
- •Patients in Phase I study will be enrolled with refractory or relapsed B-cell non-Hodgkin lymphoma.
- •Patients enrolled in the phase I study failed two or more lines of treatment regimens; Patients with mantle cell lymphoma should also be patients with contraindications or failure of BTK inhibitor therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score is 0~
- •Have life expectancy ≥ 3 months.
- •Major organ functions meet the following criteria:
- •In the absence of growth factor support therapy or blood transfusion in the last 14 days: absolute neutrophil count ≥1.5×109/L, hemoglobin ≥80 g/L, platelets ≥75×109/L (no platelet transfusion within 14 days); if accompanied with bone marrow invasion, neutrophils ≥1.0×109/L, platelets ≥50×109/L.
- •Biochemistry: Total bilirubin ≤1.5×ULN or ≤3.0×ULN in Gilbert's syndrome, AST or ALT ≤2.5×ULN, serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
- •Coagulation function: International normalized ratio (INR) and activated partial thrombin time ≤ 1.5 × ULN.
排除标准
- •Present or prior history of other malignancies (except cured carcinoma in situ of cervix and basal cell carcinoma of skin), unless there is radical treatment and no evidence of recurrence or metastasis within the last 2 years.
- •Lymphomas involved the central nervous system.
- •Patients with history of organ transplantation or allogeneic hematopoietic stem cell transplantation; patients who have received autologous hematopoietic stem cell transplantation or CAR-T treatment within the past 3 months,
- •Patients who are suitable and ready for autologous stem cell transplantation.
- •History of eye surgery or trauma within 3 months before the screening visit, history of serious eye infection or the most recent eye surgery within 4 weeks before the screening visit.
- •Has had active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
- •Has had uncontrolled or significant cardiovascular diseases, including:
- •Women who are lactating or pregnant.
- •Women of child-bearing potential who do not agree to have two pregnancy tests prior to first dose (at least one of tests is serum pregnancy test) and the test result shall be negative.
- •Male patients who do not agree to the birth control measures.
- •Any conditions that in the opinion of the investigator considers inappropriate to participate in the study.
研究组 & 干预措施
Single arm
Experimental
dose exploration
干预措施: MS-553 (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: up to 24 months
To determine the MTD and RP2D of oral MS-553 in patients with BCL
时间窗: about 8 months
Incidence of dose limiting toxicity (DLT)
时间窗: First cycle (28 days)
次要结局
- Objective response rate (ORR)(up to 24 months)
- overall survival (OS)(up to 24 months)
- Duration of response (DOR)(up to 24 months)
- time to progression (TTR)(up to 24 months)
- disease control rate (DCR)(up to 24 months)
- Pharmacokinetics parameters: Tmax(within the first 2 cycles (56 days))
- progression-free survival (PFS)(up to 24 months)
- Pharmacokinetics parameters: T1/2(within the first 2 cycles (56 days))
- Pharmacokinetics parameters: Cmax(within the first 2 cycles (56 days))
- Pharmacokinetics parameters: AUC0-12(within the first 2 cycles (56 days))
- Pharmacokinetics parameters: CL/F(within the first 2 cycles (56 days))
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's LymphomaNon-Hodgkin LymphomaNCT05950165Cho Pharma Inc.37
尚未招募
2 期
A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast CancerNSCLCTNBCNCT06746870ImmuneOnco Biopharmaceuticals (Shanghai) Inc.148
已完成
2 期
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular CarcinomaHepatocellular CarcinomaNCT05864105Biotheus Inc.35
终止
1 期
Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)Small Cell Lung Cancer and Breast CancerNCT03773133Ipsen9
招募中
1 期
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic CancerCervix CancerMetastatic CancerOvarian CancerAdvanced CancerGynecologic CancerNCT06215950Chongqing Precision Biotech Co., Ltd36