MT2021-27 Intraperitoneal FT538 With Intravenous Enoblituzumab in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Determine Maximum Tolerated Dose (MTD) of FT538
研究概览
简要总结
To determine the maximum tolerated dose (MTD) of FT538 monotherapy when administered via intraperitoneal (IP) catheter and in combination with intravenous (IV) enoblituzumab in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirements (no limit to the maximum number of prior treatments).
- •Platinum Resistant: may receive FT538 as 2nd line (as 1st salvage therapy).
- •At least 18 years of age at the time of consent.
- •GOG Performance Status 0, 1, or 2 (refer to Appendix I).
- •Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu or enoblituzumab) start
- •Pulmonary Function: Oxygen saturation ≥ 90% on room air; PFTs are performed only if known history or as medically indicated - if done, must have pulmonary function >50% corrected DLCO and FEV
- •Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI; no clinically significant cardiovascular disease including any of the following: stroke or myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher (Appendix I).
排除标准
- •Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months.
- •Currently receiving or likely to require systemic immunosuppressive therapy
- •Active autoimmune disease requiring systemic immunosuppressive therapy.
- •History of severe asthma and currently on chronic systemic medications.
- •Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy.
- •Receipt of any biological therapy, chemotherapy, or radiation therapy (except palliative RT), within 2 weeks prior to the first dose of FT538
- •Live vaccine within 6 weeks prior to start of lympho-conditioning.
- •Known allergy to the following FT538 components: albumin (human) or dimethyl sulfoxide (DMSO).
- •Prior enoblituzumab.
- •Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment. (Refer to Section 5.1.8 regarding history of brain metastases.)
- •Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic viral hepatitis is allowed.
- •Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to patient.
- •Any medical condition or clinical laboratory abnormality that, per investigator judgement, precludes safe participation in and completion of the study or that could affect compliance with protocol conduct or interpretation of results.
研究组 & 干预措施
IP FT538 monotherapy
Level -1: IP FT538 monotherapy 5 x 10^7 cells/dose Level 1: IP FT538 monotherapy 1 x 10^8 cells/dose Level 2: IP FT538 monotherapy 3 x 10^8 cells/dose Level 3: IP FT538 monotherapy 1 x 10^9 cells/dose Level 4: IP FT538 monotherapy 1.5 x 10^9 cells/dose
干预措施: FT538 (Drug)
IP FT538 + Enoblituzumab
Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab
干预措施: FT538 (Drug)
IP FT538 + Enoblituzumab
Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab
干预措施: Enoblituzumab (Biological)
结局指标
主要结局
Determine Maximum Tolerated Dose (MTD) of FT538
时间窗: 48 months
The primary objective of the study is to determine the maximum tolerated dose (MTD) of FT538 monotherapy when administered via intraperitoneal (IP) catheter and in combination with intravenous (IV) enoblituzumab in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer. Monitor the patient for signs of acute infusion related reaction during and after IP infusion. For IV infusion signs of a possible reaction are rigors and chills, rash, urticaria, hypotension, dyspnea, and angioedema.
次要结局
- Overall Response Rate (ORR)(72 months)
- Determine Progression-free Survival (PFS)(72 months)
- Adverse Events(72 months)