NCT05079282招募中1 期
An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 217
- 试验地点
- 20
- 主要终点
- Estimate of Maximum Tolerate Dose (MTD)
研究概览
简要总结
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T 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
- •Patients aged ≥ 18 years at time of screening
- •Written informed consent by the patient or the patients' legally authorized representative prior to screening
- •Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:
- •Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL)
- •Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
- •Patients must have received at least 2 prior systemic therapies
- •Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
- •Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
- •Life expectancy of at least 3 months
- •Adequate bone marrow, renal and hepatic functions
排除标准
- •Patients with central nervous system (CNS) involvement
- •Patients with Adult T-cell leukemia/lymphoma (ATLL)
- •Prior allogeneic stem cell transplant
- •Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
- •Patients with malignancies (other than T-cell lymphoma) except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years
- •History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
- •History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
- •Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
- •Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
- •Women who are pregnant or lactating
研究组 & 干预措施
ONO-4685 monotherapy
Experimental
Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy
干预措施: ONO-4685 (Drug)
结局指标
主要结局
Estimate of Maximum Tolerate Dose (MTD)
时间窗: Up to 3 weeks
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
时间窗: Through study completion, an average of 1 year
Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.
次要结局
- Plasma Concentration of ONO-4685(Up to 48 weeks)
- Plasma Concentration of Anti-Drug Antibody (ADA)(Up to 48 weeks)
- Antitumor Activity of ONO-4685(Through study completion, an average of 1 year)
研究者
研究点 (20)
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