Single-center, Phase 1 Clinical Trial Evaluating the Safety and Preliminary Efficacy of a Combination Cellular Immunotherapy in Patients With Metastatic (Stage IV) Solid Tumors Refractory to standard-of Care Therapies.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events (AEs)
研究概览
简要总结
To evaluate the safety and potential efficacy of combined immune cell therapy in patients with stage IV solid tumors who have failed standard treatment and have unresectable lesions or metastatic lesions.
详细描述
The combined immune cell therapy has a strong potential to improve treatment outcomes in several cancers, but problems related to manufacturing complexity, immunocompatibility, and poteintial toxicity may also arise. This clinical study was designed to address these challenges and to establish the safety and potential efficacy of combined immune cell therapy for unresectable solid tumors. This is a phase I study to evaluate the safety and potential efficacy of combined immune cell theapy, and obtain the recommended dose and infusion plan.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who have been histologically or cytologically confirmed as adenocarcinoma among solid tumors
- •Those with at least one measurable or evaliable lesion by RECIST v1.1
- •Those who fail standard treatment for metastatic solid tumors (failure of treatment is defined as failure of not only progression of the disease or recurrence after treatment, but also unacceptable side effects or maintenance of the treatment process)
- •ECOG performance status 0 or 1 person
- •A person who can draw about 100 cc of whole blood for the manufacture of immune cells
- •Weight: More than 50 kg for men and more than 35 kg for women
- •Hb: 9.0 g/dL or higher (registerable if hemoglobin levels recover to 10.0 g/dL or higher during the screening period); however, transfusions within 7 days prior to screening to meet this standard are not allowed)
- •Appropriate contraceptive regimen up to 2 months after clinical research drug administration
- •A person who voluntarily decides to participate after receiving a sufficient explanation for this clinical study and agrees in writing
排除标准
- •Brain Metastasis patients who have symptoms or need treatment [However, patients with stable brain metastasis who have no symptoms and do not need treatment (excluding anticonvulsants in maintenance therapy) can register]
- •A person with a systemic disease that is inappropriate to administer anticancer drugs according to the researcher's judgment
- •Those with the following cardio-cerebrovascular diseases as of the time of screening
- •a person who is HIV-positive
- •Those determined that the researcher was not suitable for participation in this clinical study as a result of the active infection (HBV, HCV) test
- •a person with acute or severe infection
- •Those who have autoimmune diseases or have a history of chronic or recurrent autoimmune diseases
- •Those with a history of organ transplants
- •a hematopoietic stem cell transplant patient
研究组 & 干预措施
SDH-Combi
natural killer (NK) cells and cytotoxic T lymphocytes (CTLs)
干预措施: Combi (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events (AEs)
时间窗: 6 months
All AEs will be collected and graded according to NCI-CTCAE v5.0. Data will be reported as the number and percentage of participants experiencing ≥1 AE.
Number of participants with serious adverse events (SAEs)
时间窗: 6 months
SAEs will be assessed for type, severity, and relationship to the investigational product. Reported as the number and percentage of participants experiencing ≥1 SAE.
次要结局
- Objective Response Rate (ORR) assessed by RECIST v1.1(6 months)
- Disease Control Rate (DCR) assessed by RECIST v1.1(6 months)
- Change from baseline in EORTC QLQ-C30 global health status/quality of life score(6 months)
研究者
Nyamdavaa Tuul
Director
Seoul Hospital