NCT07081646招募中1 期
A Phase 1b/2 Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B Cell Maturation Antigen in Participants With Relapsed or Refractory AL Amyloidosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 19
- 主要终点
- Phase 2: Proportion of Participants Achieving Complete Response
研究概览
简要总结
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
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
- •Confirmed histopathological diagnosis of AL amyloidosis
- •One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
- •Measurable hematologic disease: dFLC > 20 mg/L or serum M-protein > 5g/L
- •Relapsed or refractory disease with a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
- •ECOG performance status of 0 to 2
- •Must be able and willing to adhere to the study visit schedule and other protocol requirements
- •Women of child-bearing potential (WCBP) must have a negative serum and/or urine pregnancy test result prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use highly effective methods of birth control throughout the study.
排除标准
- •Have any other form of amyloidosis other than AL amyloidosis
- •Mayo Stage IIIb AL amyloidosis
- •Oxygen saturation < 95% on room air
- •Systolic blood pressure <100mmHg
- •NYHA class III or IV
- •Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator
- •Prior therapies:
- •CAR T cell therapy directed at any target
- •Prior BCMA-targeting therapy
- •Prior treatment with any FDA approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months.
- •Toxicity from previous anti-cancer or anti-PC-directed therapy did not resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
- •Active plasma cell leukemia at the time of screening
- •Symptomatic multiple myeloma (defined as clonal bone marrow plasma cells ≥10% plus at least one myeloma-defining event per IMWG 2014)
研究组 & 干预措施
AZD0120
Experimental
Participants will receive weight-based dose of AZD0120.
干预措施: AZD0120 (Drug)
结局指标
主要结局
Phase 2: Proportion of Participants Achieving Complete Response
时间窗: Through study completion, a minimum of 6 months
Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse Events
时间窗: Through study completion, a minimum of 6 months
Phase 2: Proportion of Participants Experiencing a Complete Response
时间窗: Through study completion, a minimum of 6 months
次要结局
- Phase 1b: Levels of AZD0120 in blood over time in participants with AL amyloidosis(Through study completion, a minimum of 6 months)
- Phase 2: Percentage of participants achieving hematologic response(Through study completion, a minimum of 6 months)
研究者
研究点 (19)
Loading locations...
相似试验
已完成
1 期
AZD1152 in Patients With Advanced Solid MalignanciesTumorsNCT00338182AstraZeneca43
终止
1 期
AZD1152 in Patients With Advanced Solid Malignancies-Study 1Solid TumorsNCT00497731AstraZeneca70
终止
1 期
AZD1152 in Patients With Advanced Solid Malignancies-Study 3Solid TumoursNCT00497679AstraZeneca45
已完成
1 期
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy ParticipantsHealthy Participants StudyNCT06311760AstraZeneca17
已完成
1 期
Open Label, Dose Escalation Phase I Study of AZD2281Advanced Solid MalignanciesNCT00572364AstraZeneca18