2025-524915-36-00招募中2 期
A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity
研究概览
简要总结
To evaluate the safety and tolerability of GSK5926371 in participants with relapsed or refractory B-NHL to establish the Recommended dose for expansion (RDE) and/or Recommended Phase 2 dose(s) (RP2D).
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Part 1: GSK5926371 Dose Escalation & Backfill
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age at the time of signing the ICF
- •Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated, a) Has measurable disease, b) Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication. For indications for which CD19-directed CAR-T therapy is approved, the participant must have received such prior CAR-T therapy unless deemed ineligible, does not have access to it or has declined this treatment; c) Has documented disease relapse, progression or disease refractory to the most recent line of therapy, per Lugano criteria.
- •Willing to use adequate contraception (Participant of childbearing potential [POCBP] only)
- •Is capable of giving signed informed consent
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Has adequate organ function.
排除标准
- •Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.
- •Has significant cardiovascular disease such as uncontrolled arrhythmias, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, ejection fraction 45% by any methods in the 12 months of enrollment, unstable angina or acute coronary syndrome including myocardial infarction within 6 months of enrollment.
- •Has had any major surgery within 4 weeks prior to the first dose of GSK5926371 or has not recovered from prior surgeries or complications.
- •Has a history of Progressive multifocal leukoencephalopathy (PML), current central nervous system (CNS) involvement by lymphoma, or a history of significant CNS disease such as uncontrolled seizures, stroke, epilepsy, CNS vasculitis, and neurodegenerative conditions
- •Has an active or chronic infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug.
- •Has received a prior Allogeneic stem cell transplant (allo-SCT) within 12 months prior to the first dose of GSK5926371 or has active graft-versus-host disease requiring systemic immunosuppressive therapy.
- •Has received a prior autologous stem cell transplant within 100 days prior to the first dose of GSK
- •Has received prior treatment with Chimeric antigen receptor Tcell (CAR-T) therapy within 12 weeks of first GSK5926371 administration.
- •Has received prior treatment with CD19- or CD20-targeting Bispecific antibody (BsAbs) within 8 weeks of the first dose of study intervention.
- •Has QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block.
结局指标
主要结局
Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity
Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity
Number of participants with dose limiting toxicities (DLTs)
Number of participants with dose limiting toxicities (DLTs)
次要结局
- Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)
- Overall Response Rate (ORR)
- Maximum concentration (Cmax) of GSK5926371
- Time to Cmax (Tmax) of GSK5926371
- Area under the curve (AUC) of GSK5926371
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (16)
Loading locations...
相似试验
尚未招募
1 期
A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHLNCT07607925GlaxoSmithKline49
尚未招募
1 期
Clinical Study of SYS6055 Injection in Participants With Relapsed/Refractory Aggressive B-Cell LymphomaNCT07476066Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd374
招募中
1 期
GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube CancerPlatinum-resistant Ovarian CancerNCT07489287Roswell Park Cancer Institute18
招募中
2 期
A Phase 1/2a Study of BMS-986523 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid MalignanciesAdvanced Solid Tumor Malignancies2025-523547-35-00Bristol-Myers Squibb Services Unlimited Company16
尚未招募
1 期
A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica PatientsNCT07573332University of Texas Southwestern Medical Center5