NCT02545361撤回1 期
A Phase 1/2a, Multi-center, Dose Escalation, 2 Stages Study to Evaluate the Safety, Tolerability, and Anti-cancer Activity of Subcutaneously Administered KAHR-102 for the Treatment of Lymphoma Patients Who Express Both B7 and FasR
Kahr Medical0 个研究点开始时间: 2018年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluate incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and to determine the Dose Limiting Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.
详细描述
Subjects will have a screening visit for determination of eligibility. Up to 40 evaluable subjects will be included in the study; up to 30 in stage 1, and 10 in stage 2.
The study is divided into 2 stages:
- Dose escalation - Stage 1A and 1B
- Dose Confirmation Phase - Stage 2
Stage 1A:
Will start with 3 subjects receiving premedication (20mg Dexamethasone Intravenous (IV), 10mg Loratadine Per Os (P.O), and 1gr Paracetamol (P.O), 1 hour before treatment) with 2 micrograms/kilograms (µg/kg) KAHR-102 subcutaneous (SC) injection every 14 days for 3 injections. 3 injections will be defined as 1 cycle.
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
- •Subjects diagnosed with recurrent malignant lymphoma, which express B7 and FasR and have either failed to respond to standard therapy, relapsed and for whom no standard therapy is available.
- •Measurable disease as measured by "Lugano" Classification.
- •A measurable node must have a longest diameter (LDi) greater than 1.5 cm. Measurable extranodal disease (eg, hepatic nodules) may be included in the six representative, measured lesions. A measurable extranodal lesion should have an LDi greater than 1.0 cm
- •Biopsy of tumor stains positive to cluster of differentiation 95 (CD95) and to Cluster of Differentiation 80 (CD80) or Cluster of Differentiation 86 (CD86) or both within the last 6 months.
- •If greater than 6 months , a fine-needle aspiration (FNA) should be performed
- •Men and Women age >
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Estimated life expectancy of at least 2 months.
- •Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase, aspartate aminotransferase ≤2× ULN).
- •Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥30 ml/min/1.73m2 as measured by Cockcroft -Gault / CKD (Chronic Kidney Disease)/EPI (Epidemiology Collaboration) formulas.
- •Platelet count ≥ 50,000 and an absolute neutrophil count (ANC) ≥ 1500 /mm
- •Women of child bearing potential practicing an acceptable method of birth control.
- •Understanding of study procedures and willingness to comply for the entire length of the study and to give written informed consent.
排除标准
- •Other standard anti-neoplastic therapies are available.
- •Known Central Nervous System (CNS) lymphoma.
- •Chronic lymphocytic leukemia and autoimmunity leukemia.
- •Known hypersensitivity to the study drug or to any of its components.
- •Chronic heat failure (CHF) New-York heart association (NYHA) = Class IV.
- •Known Chronic Obstructive Pulmonary Disease (COPD) > Stage 3 (Forced Expiratory Volume -(FEV1)<50%, FEV1/Forced Vital Capacity (FVC)<70%).
- •Chronic kidney disease (CKD) >Stage 4 (subjects with known Filtration rate (FR)<30 milliliter (mL)/min/1.73m2).
- •Cirrhosis (Child-Pugh Class C score).
- •Known hypersensitivity to drug components.
- •Prior chemotherapy within 3 weeks, nitrosureas within 6 weeks, therapeutic anticancer antibodies within 3 weeks, radio or toxin immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 28 days of first dose of the study drug.
- •American Society for Cytotechnology (ASCT) and prior allogeneic stem cell transplantation (SCT)< 12 weeks prior to first dose of the study drug.
- •Myelosuppressive treatment within 2-3 weeks of entering this study. Prednisone allowed.
- •Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study.
- •Positive test for acquired immune deficiency syndrome (AIDS).
- •Any positive test for hepatitis B or hepatitis C virus (HBV or HCV) indicating acute or chronic infection (HBsAg, HBcAb total and anti-HCV Abs).
- •Presence of uncontrolled infection.
- •Evidence of active bleeding or bleeding susceptibility or medically significant hemorrhage within prior 30 days.
- •Coumadin therapy.
- •Pregnant or lactating.
- •Treatment with other investigational drugs within 14 days of start of this study.
- •Prisoners or subjects who are involuntarily incarcerated.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
研究组 & 干预措施
KAHR002
Experimental
premedication (20mg Dexamethasone (IV), 10mg Loratadine (P.O), and 1gr Paracetamol (P.O), 1 hour before treatment) with 2µg/kg KAHR-102 subcutaneous (SC) injection
干预措施: KAHR-102 (Drug)
结局指标
主要结局
Evaluate incidence of adverse events
时间窗: Up to 9 months
Safety, as determined by frequency, nature, and severity of adverse events; and the profile of dose limiting toxicities.
次要结局
- Blood samplings for KAHR-102 levels(Stage 1A: Pre-dose, days 1, 2, 28, 29 (Injections 1 and 3). Stages 1B and 2: Pre-dose, days 1, 2 ,14 ,15 (Injections 1 and 3). Repeated on Day 4, 7, 32 and 35.)
- Blood sampling for Anti-Drug Antibodies (ADAs)(Stage 1A: Pre-dose day 1, 14, 28 in all cycles, day 49; Stages 1B and 2: Pre-dose day 1 and 28 in all cycles, day 35.)
- Tumors measurements(Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.)
- Optional "LUGANO" classification response(Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.)
研究者
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