NCT07030907招募中1 期
A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101.
Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.
详细描述
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART™ designed IL-2 cytokine in platinum-resistant ovarian cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age at the time of signing the informed consent form.
- •Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
- •Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
- •Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
- •Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
- •Measurable disease.
- •Consent to provide archived tumor tissue sample.
- •ECOG performance status of 0 or
- •Adequate organ function.
- •Alkaline phosphatase ≤ 2.5 x ULN
- •≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) > 92% on room air.
- •Life expectancy of ≥ 3 months
- •Adequate venous access.
- •Negative screen for infectious disease markers.
- •Negative serum pregnancy test.
- •Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.
- •Note: Other protocol defined inclusion criteria could apply
排除标准
- •Women of child-bearing potential who are pregnant or breastfeeding.
- •Uncontrolled bacterial, fungal, or viral infections.
- •Active infection requiring systemic therapy.
- •Bleeding or thrombotic disorders or at risk for severe hemorrhage.
- •Any form of primary immunodeficiency.
- •Had an allogenic tissue/solid organ transplant.
- •Active autoimmune disease.
- •Concurrent treatment with systemic high dose corticosteroids.
- •Unresolved acute effects of any prior therapy.
- •Active invasive cancer other than the cancer under study.
- •Significant lung disease.
- •Clinically significant pericardial effusion.
- •Prior radiotherapy within 2 weeks of start of study intervention.
- •No major surgery within 28 days prior to enrollment.
- •Received investigational agents or tumor vaccines.
- •Received chemotherapy within the previous 3 weeks.
- •History of grade ≥ 3 ascites.
- •Active CNS involvement.
- •Received a live vaccine within 30 days prior to study treatment.
- •Received prior CAR T cell therapy.
- •Received prior mesothelin targeted therapy.
- •Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply
研究组 & 干预措施
OPB-101 Treatment Arm
Experimental
干预措施: OPB-101 (Biological)
结局指标
主要结局
Safety
时间窗: 2 years
To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s)
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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