NCT07075185
招募中
1 期
A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose
概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease
- •Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody
- •Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1
- •Participants must have acceptable laboratory values as defined by the protocol
排除标准
- •Participants must not have known central nervous system (CNS) involvement with myeloma
- •Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis
- •Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy
- •Participants cannot require systemic steroids for any condition
研究组 & 干预措施
KLN-1010
Experimental
Drug: KLN-1010 specified dose given once
干预措施: KLN-1010 (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose
时间窗: Up to 15 years from dosing of KLN-1010
All adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria
次要结局
- Pharmacokinetics of KLN-1010 after dosing.(Up to two years after dosing with study drug.)
- Pharmacokinetics of KLN-1010 (Tmax).(Up to two years after infusion with study drug.)
- Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)(Up to two years after infusion with study drug.)
- Pharmacokinetics of CAR-T cells generated.(Up to two years after infusion with study drug.)
- Pharmacokinetics of CAR-T cells generated (Tmax).(Up to two years after infusion with study drug.)
- Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC)(Up to two years after infusion with study drug.)
- Assessment of Multiple Myeloma(From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.)
研究者
研究点 (10)
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