NCT03902184进行中（未招募）2 期
TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 53
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- •Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening;
- •Receipt of live vaccines within 4 weeks prior to treatment;
- •Central nervous system (CNS) lymphoma involvement;
- •Prior administration of IPH4102;
- •Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study;
- •Autologous stem cell transplantation less than 3 months prior to enrollment;
- •Prior allogenic transplantation;
- •Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
- •Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
- •Patients who have Hepatitis B Virus infection determined as HBsAg positive and / or Hepatitis C Virus infection determined as detection of HCV RNA in serum or plasma by a sensitive quantitative molecular method;
- •Known or tested positive for human immunodeficiency virus (HIV);
- •Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ
- •Pregnant or breastfeeding women;
- •Known clinically significant cardiovascular disease or condition, including:
- •Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification;
- •Any uncontrolled arrhythmia (per the investigator's discretion);
- •Uncontrolled hypertension (per the investigator's discretion).
- •Patients with autoimmune disease on systemic immunosuppressive treatment;
- •Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;
- •Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
研究组 & 干预措施
Cohort 1: Relapsed/refractory Sezary Syndrome
Experimental
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
干预措施: IPH4102 (Biological)
Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing
Experimental
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
干预措施: IPH4102 (Biological)
Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed)
Experimental
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
干预措施: IPH4102 (Biological)
Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing
Experimental
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
干预措施: IPH4102 (Biological)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From the first dose until study completion, an expected average of 2 years
Using the Olsen (2011, JCO) criteria (All cohorts)
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)(From first dose until study completion, an expected average of 2 years)
- Overall survival (OS) (All cohorts)(From the first dose until study completion, an expected average of 2 years)
- Immunogenicity of IPH4102 alone (All cohorts)(From the first dose until study completion, an expected average of 2 years)
- PK parameters : Maximum Plasma Concentration of IPH4102 alone (All cohorts)(From the first dose until study completion, an expected average of 2 years)
- Duration of Response (DOR)(From the first dose until study completion, an expected average of 2 years)
- Quality of life (QoL) (All cohorts)(Through study completion, an expected average of 2 years)
- pruritus (All cohorts)(Through study completion, an expected average of 2 years)
- ORR using blinded central review (Cohort 1)(From the first dose until study completion, an expected average of 2 years)
- Progression free survival (PFS) (All cohorts)(From the first dose until study completion, an expected average of 2 years)
- PK parameters :Trough Concentration of IPH4102 alone (All cohorts)(From the first dose until study completion, an expected average of 2 years)
研究者
研究点 (53)
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