A First-in-human, Open-label, Clinical Study to Assess the Safety, Tolerability, and Activity of OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations.
研究概览
简要总结
The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001.
Participants will:
Receive a short course of chemotherapy before OT-C001 treatment. During the study treatment, participants will recieve weekly dose of OT-C001 for 3 or 6 weeks. During the study period, participants will also receive another two drugs, rituximab and IL-2, to support OT-C001 treatment.
Participants need to visit the clinic or may be hospitalized according to the study plan.
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
- •≥18 years of age
- •histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy
- •with evaluable disease
- •with adequate biological parameters at baseline
- •ECOG performance status ≤1
- •life expectancy >3 months as assessed by the investigator
排除标准
- •Receive concomitantly any antitumor-directed drug therapy
- •Any vaccination with live virus vaccines before or during treatment
- •With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
- •Major surgery within 3 weeks
- •With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement
- •Ongoing immune-related tocivities or adverse events grade >1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
- •Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
- •Primary or secondary immune deficiency
- •Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
- •Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV
- •Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months
- •Dementia or altered mental status that would prohibit informed consent
- •Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes
研究组 & 干预措施
Cohort 1 (Dose Level 1)
OT-C001 1 vial, weekly dosing
干预措施: allogenic natural killer cells (Biological)
Cohort 2 (Dose Level 2)
OT-C001 3 vials, weekly dosing
干预措施: allogenic natural killer cells (Biological)
Cohort -1 (Sub Dose Level)
OT-C001 1/3 vial (100M)
干预措施: allogenic natural killer cells (Biological)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations.
时间窗: All assessments will be conducted from first study treatment administration through the End of Treatment or Early Termination Visit (scheduled within 14 days after the last dose).
次要结局
- Antitumor activity characterized by objective response rate per Lugano criteria.(Tumor will be assessed at the end treatment cycles (3 and 6 weeks after the first dose), and every 12 weeks afterwards for up to of 2 years until progression of disease or starting new anti-cancer treatments.)