A Phase 1 Study Of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- During Dose Expansion - estimate duration of response (DOR) of MT-601
研究概览
简要总结
The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen for patients with pancreatic cancer. The main question[s] it aims to answer are: safety and efficacy • overall response rate and duration of response. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.
详细描述
The Dose Escalation portions will proceed using a standard 3+3 design. Flat doses of MT-601 will be administered ranging from 200 million cells to 400 million cells. For the Dose Expansion, MT-601 will be administered at the dose determined to be safe based on the results from the Dose Escalation portion. Front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) will be administered as per standard of care. MT-601 will be administered intravenously over 10 minutes (± 5 minutes) during the "off" week of front-line chemotherapy. Patients will receive up to 6 infusions of MT-601 approximately every 4 weeks.
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
- •Cytologically or histologically confirmed newly diagnosed locally advanced, unresectable or metastatic pancreatic adenocarcinoma (excluding other pancreatic malignancies such as acinar cell carcinomas or neuroendocrine cell neoplasms, etc.).
- •Eligible for reassessment following 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel): Patient must have experienced a response of SD, PR, or CR per RECIST v1.1 after 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel).
- •≥18 years of age prior to administration of MT-
- •Measurable or evaluable disease per RECIST v1.1 at the time of screening.
- •Must have sufficient leukapheresis material to manufacture autologous MT
- •Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Life expectancy ≥12 weeks.
- •Pulse oximetry of >90% on room air in patients with previous radiation therapy.
- •Adequate organ function, as defined below:
- •Absolute neutrophil count (ANC) ≥1.5 × 109/L
- •Platelets ≥75 × 109/L
- •Hemoglobin ≥9 g/dL (can be transfused)
- •International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) (unless patient receiving stable dose of anticoagulant therapy as long as PT or INR in therapeutic range of intended anticoagulant)
- •Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) PTT or aPTT ≤ 5 seconds above ULN (unless patient receiving stable dose of anticoagulant therapy "a" as long as PT or INR in therapeutic range of intended anticoagulant)
- •Total bilirubin ≤2 × ULN
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN OR ≤5 × ULN if liver has tumor involvement
- •Serum creatinine OR calculated (as per institutional standards) creatinine clearance ≤2 × ULN OR measured or calculated ≥50 mL/min for patients "a" If receiving anticoagulation, the patient must have no active bleeding within 14 days prior to baseline assessment.
- •Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence between initiation of screening for MT-601 infusion and 6 months after the last MT-601 infusion. Male patients who are sexually active must agree to use a condom during this period.
- •Disease imaging prior to administration of front-line chemotherapy and reimaging prior to administration of MT-601.
排除标准
- 未提供
结局指标
主要结局
During Dose Expansion - estimate duration of response (DOR) of MT-601
时间窗: Through study completion. Approximately 3 years
To estimate duration of response (DOR)of MT-601 administered during the off week of chemotherapy regimen (RECIST v1.1) DRR to be measured by disease assessments conducted prior to treatment, at baseline, 8 weeks, 16 weeks and during active follow-up visits which will occur every 8 weeks (starting from Week 24), using RECIST v1.1
During Dose Escalation - assess the safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen.
时间窗: Through study completion. Approximately 3 years
* Dose-limiting toxicities (DLTs) * Safety (including but not limited to): treatment-emergent adverse events, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE, Version 5.0
During Dose Expansion - estimate overall response rate (ORR) of MT-601
时间窗: Through study completion. Approximately 3 years
To estimate overall response rate (ORR) of MT-601 administered during the off week of chemotherapy regimen (RECIST v1.1) ORR to be measured by disease assessments conducted prior to treatment, at baseline, 8 weeks, 16 weeks and during active follow-up visits which will occur every 8 weeks (starting from Week 24), using RECIST v1.1
次要结局
- During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601(Through study completion. Approximately 3 years)
- During Dose Expansion - assess safety and tolerability of MT-601(Through study completion. Approximately 3 years)