NCT06375733招募中1 期
A Phase Ib/II, Multicenter, Open-label, Single-arm Study to Assess the Safety and Efficacy of GFH009 in Combination With Zanubrutinib in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
适应症
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
- 51
- 试验地点
- 2
- 主要终点
- Phase Ib: adverse events(AEs)
研究概览
简要总结
This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 old.
- •Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL), high-grade B-cell lymphoma, or large B-cell lymphoma transformed from indolent B-cell lymphoma (including but not limited to Richter syndrome, transformed follicular lymphoma, transformed MZL) (2016 WHO classification).
- •Relapse or refractory after receiving 2~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab.
- •Must have a measurable lesion.
- •The patient is not suitable to receive stem cell transplantation judged by the investigator.
- •The Eastern Cooperative Oncology Group (ECOG) performance status score (PS) is 0~
- •Have adequate organ function, including:
- •i. Hematopoietic function: absolute neutrophil count (ANC) ≥1.0×109/L, platelet count (PLT) ≥75×109/L and hemoglobin (Hgb) ≥ 80 g/L.
- •ii. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- •iii. Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN, or serum creatinine clearance ≥ 50 mL/min when Cr > 1.5× ULN.
- •iv. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
排除标准
- •Primary or secondary central nervous system (CNS) lymphoma.
- •Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect and other investigational drugs or device therapy within 28 days or 5 half-lives (whichever is shorter), or received therapeutic or palliative radiotherapy within 14 days, or received CAR-T therapy within 12 weeks prior to the administration of the study drugs.
- •Patients with primary resistance to CDK9 or BTK inhibitors.
- •Has a history of organ transplantation or allogeneic stem cell transplantation. Patients who have undergone autologous stem cell transplantation within 6 months.
- •Other malignancies within 2 years prior to study entry, excluding appropriately treated carcinoma in situ of the cervix, focal squamous cell carcinoma of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle-invasive urothelial carcinoma.
- •Have significant diseases of the cardiovascular system or significant acute or chronic infection. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. Presence of significant gastrointestinal disorders. Current clinically significant interstitial lung disease, radiation pneumonitis, or drug-associated pneumonia requiring treatment. Accompanied by other poorly controlled systemic diseases, such as hypertension, diabetes mellitus, etc.
- •Has a history of bleeding disorder or a history of spontaneous bleeding requiring blood transfusion or other medical intervention. Active bleeding within 2 months prior to the first dose.
- •Surgical procedures (excluding needle biopsies) that may affect the administration or study evaluation of this study within 28 days prior to the first dose.
- •Patients who have been treated with prednisone (or equivalent doses of glucocorticoids) at >20 mg/day for anti-tumor purposes within 7 days, or who require long-term use of glucocorticoids for non-anti-tumor therapy.
- •Ongoing medical treatment with a potent inhibitor or inducer of CYP3A is required.
研究组 & 干预措施
Phase 1b:GFH009 & Zanubrutinib
Experimental
干预措施: GFH009 (Drug)
Phase 1b:GFH009 & Zanubrutinib
Experimental
干预措施: Zanubrutinib (Drug)
Phase 2: GFH009 & Zanubrutinib
Experimental
干预措施: GFH009 (Drug)
Phase 2: GFH009 & Zanubrutinib
Experimental
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Phase Ib: adverse events(AEs)
时间窗: From Screening (Day -28 to Day-1) to 30 days ±7 days after the last dose, or until the start of a new anti-tumor therapy，assessed up to 32 months
Incidence of DLT events, incidence and severity of AEs and serious adverse events (SAEs), Electrocardiogram changes
Phase II: ORR
时间窗: From Screening (Day -28 to Day-1) to 30 days ±7 days after the last dose,or until the start of a new anti-tumor therapy, assessed up to 32 months
ORR(Objective Response Rate) as assessed by the investigator according to the 2014 Lugano standards
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of BoneGiant Cell Tumor of BoneNCT04255576Shanghai JMT-Bio Inc.139
已完成
1 期
A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid TumorsSolid TumorLung CancerHCCNCT04172506Akeso65
尚未招募
1 期
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial CancerAdvanced Urothelial CarcinomaNCT06079112Mabwell (Shanghai) Bioscience Co., Ltd.100
终止
1 期
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid TumorsAcute Myeloid Leukemia (AML)Acute Lymphoblastic Leukemia (ALL)Solid TumorsNeuroblastomaNCT04029688Hoffmann-La Roche38
终止
1 期
Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCLExtranodal NK/T-cell Lymphoma, Nasal TypeNCT04509466CSPC ZhongQi Pharmaceutical Technology Co., Ltd.41