NCT07334574尚未招募1 期
A Safety, Tolerability and Efficacy Study of XP-006 Personalized Tumor mRNA Vaccine for Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)
研究概览
简要总结
The main objective of this study is to observe and evaluate the safety and tolerability of the XP-006 personalized tumor mRNA vaccine for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. Secondary objectives focus on evaluating preliminary efficacy through several parameters: XP-006-induced antigen-specific CD4+/CD8+ T cell activation levels, objective remission rate (ORR), complete remission rate (CRR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
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
- •Subjects voluntarily signed written informed consent files, able to comply with the study protocol, in the investigator's judgment.
- •Subjects must be ≥18 years of age at time of informed consent, regardless of gender.
- •B-NHL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma).
- •Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons.
- •Gene mutation and the peripheral blood HLA typing both meet the requirements of the vaccine.
- •There are evaluable lesions detected by PET/CT.
- •Life expectancy of more than 3 months.
- •ECOG 0-2 points.
- •No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : ① Absolute value of neutrophil count ≥1500/mm3; Platelet count ≥75,000/mm3 ② Total bilirubin ≤2× upper limit of normal value (ULN) ③ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (serum glutamate pyruvate aminotransferase [SGPT]) ≤3× upper limit of normal value (ULN) ④ the creatinine clearance rate was ≥60ml/min ⑤ No cardiac dysfunction.
排除标准
- •Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide);
- •Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA > detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons;
- •Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
- •Bone marrow failure, defined as ANC<1500/mm3 or platelet <75,000/mm3, unless hematologic changes are thought to be associated with lymphomas infiltrating the bone marrow;
- •Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure (NYHA) heart function grade III or IV; Or left ventricular ejection fraction <50%;
- •Lymphoma with central nervous system (CNS) involvement;
- •Those who are known to be allergic to the test drug ingredients;
- •Those who have received grade II or above surgery within three weeks before treatment;
- •Patients who have received organ transplants;
- •Has been diagnosed with or is being treated for malignancy other than lymphoma, except for: ① They have received therapeutic treatment and have not had known active disease malignancy for ≥5 years prior to enrollment; ② Basal cell carcinoma of the skin (except melanoma) without signs of disease after adequate treatment; ③ Cervical carcinoma in situ without signs of disease after adequate treatment.
- •With severe infection;
- •Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; The researchers deemed unsuitable for the group.
研究组 & 干预措施
Neoantigen tumor vaccine monotherapy arm
Experimental
Dose Escalation and Randomization Phase vaccine: 0.2mg, 0.4mg, 1 mg. Dose Expansion Phase vaccine: MTD or 1mg. 3 weeks as a treatment cycle, a total of 9 cycles.
干预措施: Personalized neoantigen tumor vaccine (Biological)
结局指标
主要结局
Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)
时间窗: Day1 to Day 21
次要结局
- Objective remission rate at the end of treatment(Up to approximately 2 years)
- Progression-Free Survival (PFS)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)
- Reaction of antigen-specific T cells in peripheral blood(Up to 104 weeks)
研究者
研究点 (1)
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