An Open-label, Multi-center, Dose-escalation and Expansion, Phase 1/2a Study to Evaluate the Safety, Tolerability, PK/PD, and Preliminary Anti-tumor Activity of GIC-102 Monotherapy in Patients With Advanced Solid Tumors, R/R Non-Hodgkin Lymphoma, and Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Dose-limiting toxicity assessment (dose escalation phase)
研究概览
简要总结
This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.
详细描述
This is a first-in-human, open-label, non-randomized, dose-escalation and expansion phase 1/2a trial to determine the safety profile and identify the maximum tolerated dose of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.
This study will comprise two phases.
- GIC-102 monotherapy dose escalation Phase
- GIC-102 monotherapy dose expansion phase
GIC-102 is an "off-the-shelf" allogeneic natural killer cells isolated from non-HLA-related healthy donor. Natural killer cells are innate immune cells that show strong cytolytic function against physiologically stressed cells such as tumor cells and virus infected cells.
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
- 19 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
- •Clinically significant cardiovascular disease within 24 weeks
- •Primary malignant tumor other than the indications for this study
- •The following diseases
- •Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks
- •The New York Heart Association class III/IV
- •Active hepatitis B virus or hepatitis C virus infection
- •Human immunodeficiency virus positive
- •Clinically significant symptoms or uncontrolled central nervous system metastasis
- •Previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study
- •Received chemotherapy other than pre-conditioning within 4 weeks
- •Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks
- •Hypersensitivity reactions to the study drug or excipients
- •Hypersensitivity to cyclophosphamide or fludarabine
- •Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks
- •Have previously received an allogeneic tissue/solid organ transplant
- •Have administered other investigational drug or applied other investigational medical device within 4 weeks
- •Pregnant or lactating female subjects
- •Male subjects who did not agree to use contraception or to maintain abstinence
研究组 & 干预措施
Dose escalation phase: GIC-102 monotherapy
- Low Dose level 1: 1 x 10^9 cells
- Mid Dose level 2: 3 x 10^9 cells
- High Dose level 3: 1 x 10^10 cells
干预措施: GIC-102 (Drug)
Dose expansion phase: GIC-102 monotherapy
- Dose level: RP2D
干预措施: GIC-102 (Drug)
结局指标
主要结局
Dose-limiting toxicity assessment (dose escalation phase)
时间窗: Up to 4 weeks
To determine the maximum tolerated dose of allogeneic natural killer cells
Adverse event / Immune related adverse event
时间窗: through study completion, an average of 1 year
To determine the safety of GIC-102
Objective Response Rate (ORR) (dose expansion phase)
时间窗: through study completion, an average of 1 year
To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)
次要结局
- PK Profile (dose expansion phase) - Tmax(up to 6 months)
- Overall survival (OS)(Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase))
- Duration of response (DOR)(Through study completion)
- PK Profile (dose expansion phase) -Cmax(up to 6 months)
- PK Profile (dose expansion phase) - AUC(up to 6 months)
- Objective response rate (ORR) (dose escalation phase)(through study completion, an average of 1 year)
- Progression free survival (PFS)(Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase))
- Disease Control Rate (DCR)(through study completion, an average of 1 year)