NCT07652138招募中1 期
An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年7月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs)
研究概览
简要总结
This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate in the trial and provide written informed consent.
- •2. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.
- •3. BCMA-positive multiple myeloma documented at screening or in prior medical records.
- •4. Aged 18 - 70 years, any gender.
- •5. Life expectancy of at least 12 weeks.
- •6. Serum total bilirubin < twice the upper limit of normal (ULN); serum creatinine within normal range;
- •7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < three times ULN.
- •8. ECOG performance status score of 0 -
- •9. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.
- •10. Ability to adhere to the study visit schedule and protocol requirements.
排除标准
- •Patients with serious active infections.
- •2. Subjects with acquired or congenital immunodeficiency.
- •3. Subjects with Class III/IV heart failure per NYHA criteria.
- •4. Subjects with epilepsy or other central nervous system diseases.
- •5. Subjects with a history of primary cancer, except:
- •Resected non-melanoma (e.g., basal cell carcinoma)
- •Cured carcinoma in situ (e.g., cervical, bladder, breast cancer)
- •6. Systemic high-dose steroid use within 2 weeks before treatment.
- •7. Pregnant, breastfeeding women, or those planning pregnancy in 6 months.
- •8. Participation in other clinical trials within one month.
- •9. Major surgery within 14 days before the first study drug dose.
- •10. Any condition the investigator deems may raise subject risks or affect trial results.
研究组 & 干预措施
Allogeneic CAR-T cell therapy
Experimental
Newly Diagnosed Multiple Myeloma Patients are treated with allogeneic CAR-T cell therapy
干预措施: BCMA/CD19-targeted allogeneic CAR-T (Drug)
结局指标
主要结局
The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs)
时间窗: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.
次要结局
- Overall effectiveness and duration of efficacy(4 weeks, 3 months, 6 months, and 12 months)
- Pharmacokinetic (PK) of RN1201(Up to 52 weeks)
- Pharmacodynamic (PD) of RN1201(Up to 52 weeks)
研究者
研究点 (1)
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