NCT07053007尚未招募1 期
Phase I Trial of Umbilical Cord Blood Natural Killer Cells (CB-NK) Expressing Soluble IL-15 (sIL-15) and PD-L1 +/- Atezolizumab in Non-Small Cell Lung Cancer Patients Refractory to PD-1/PD-L1 Immune Checkpoint Inhibitors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Optimal biological dose (OBD) of NK-102 as monotherapy and when given in combination with Atezolizumab
研究概览
简要总结
This is a Phase 1 dose escalation clinical trial determining the maximum tolerated dose of NK-102 in subjects with advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC) (previously treated with PD1 and/or PD-L1 immune checkpoint inhibitors) as monotherapy or in combination with atezolizumab.
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
- •Documented informed consent of the participant
- •Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- •Age: ≥ 18 years
- •ECOG 0 to 1
- •NSCLC patients with advanced, metastatic, or recurrent disease, previously treated with a PD-1 or PDL-1 immune checkpoint inhibitor, either as single agent or in combination with chemotherapy or other immunotherapy or experimental agents
- •Radiographically demonstrated tumor progression on or after PD-1/PD-L1 immune checkpoint inhibitor treatment
- •Preserved organ function and recovery of prior drug related toxicities (except alopecia or grade 2 anemia) to grade 1 or better
- •No cytotoxic chemotherapy or immunotherapy over the three weeks prior to lymphodepletion
- •Histologically confirmed Non-Small Cell Lung Cancer
- •Measurable disease as per RECIST criteria 1.1
- •Fully recovered from the acute toxic effects (except alopecia) to ≤ Grade 1 to prior anti- cancer therapy
- •Cardiac ejection fraction ≥ 50% and no clinically significant EKG findings (same criteria must also be met for patients selected for a second course of therapy).
- •ANC ≥ 1,500/mm^3
- •Hgb ≥ 8 g/dl
- •Platelets ≥ 100,000/mm3
- •Total bilirubin ≤ 1.5 X ULN
- •AST ≤ 1.5 x ULN
- •ALT ≤ 1.5 x ULN
- •AP ≤ 1.5 x ULN
- •Creatinine within 1.5 times the normal upper limit or with a creatinine clearance of ≥ 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula
- •If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
- •Seronegative for HIV Ag/Ab combo, HCV*, active HBV (Surface Antigen Negative)
- •*If positive, Hepatitis C RNA quantitation must be performed.
- •Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 06 months after the last dose of protocol therapy.
- •Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only).
排除标准
- •Autologous stem cell transplant within 1 year prior to Day 1 of protocol therapy
- •Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to Day 1 of protocol therapy
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- •Active diarrhea
- •Clinically significant uncontrolled illness
- •Active infection requiring antibiotics
- •Known history and/or positive serology for immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
- •Diagnosis of Gilbert's disease
- •Other active malignancy
- •Females only: Pregnant or breastfeeding
- •Severe (grade 3 or higher) immune related adverse events during prior PD-1 inhibitor treatment
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- •Concomitant use of other investigational agents
- •Patients with EGFR mutations or ALK translocations in their tumors, unless treatment with the indicated tyrosine kinase inhibitor has failed
- •Active brain metastases. Previously treated brain metastasis must demonstrate stability on subsequent MRI scans.
- •Adults lacking capacity to give their informed consent will be excluded from participation
- •Cardiac ejection fraction < 50%
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
研究组 & 干预措施
NK-102 +/- Atezolizumab
Experimental
Study participants will be assigned to a protocol-specified treatment dose level.
干预措施: NK-102 (Drug)
NK-102 +/- Atezolizumab
Experimental
Study participants will be assigned to a protocol-specified treatment dose level.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Optimal biological dose (OBD) of NK-102 as monotherapy and when given in combination with Atezolizumab
时间窗: Up to 16 weeks
Determination of the optimal biological dose (OBD) will be utilized to evaluate the safety and tolerability of NK-102 or when NK-102 is given in combination with Atezolizumab.
Detection and Measurement of persistence in the peripheral blood to assess cellular kinetics of NK-102
时间窗: Samples will be collected on day 28
The number of NK-102 cells in blood will be measured to assess the persistence of infused NK-102 cells after administration.
次要结局
- Overall Response Rate (ORR)(Up to 48 months)
- Disease Control Rate (DCR)(Up to 48 months)
- Response Duration(Up to 48 months)
- Disease Control Duration(Up to 48 months)
- Progression Free Survival (PFS) Rate(At 6 months and 1 year post NK-102 cell infusion)
- Overall Survival (OS) Rate(At 6 months and 1 year post NK-102 cell infusion.)
研究者
Miguel Angel Villalona
Professor and Chief
University of California, Irvine
研究点 (1)
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