NCT06680037
招募中
1 期
A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Number of Participants with Dose-Limiting Toxicities (DLTs)
概览
简要总结
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
- •Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.
排除标准
- •History of malignancy that has not been in remission for at least 2 years.
- •Viral Screening
- •Evidence of chronic active or history of hepatitis B virus (HBV).
- •Seropositive for human immunodeficiency virus (HIV) antibody.
- •History of bone marrow/hematopoietic stem cell or solid organ transplantation.
- •Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).
- •Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Azer-cel
Experimental
Participants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.
干预措施: Azercabtagene zapreleucel (azer-cel) (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: From Day 0 to Day 28
DLT will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)(Up to Day 720)
- Change From Baseline in CAR T-cell Toxicities(Baseline, up to Day 720)
- Pharmacokinetics (PK) Plasma Concentrations of Azer-cel(Up to Day 720)
- Pharmacodynamics (PD) Plasma Concentrations of Azer-cel(Up to Day 720)
- Time to Confirmed Disability Progression (CDP)(Up to Day 720)
- Time to Confirmed Disability Improvement (CDI)(Up to Day 720)
- Change From Baseline in Brain MRI Gadolinium Enhancing T1, New or Enlarging Hyperintense T2(Baseline, up to Day 720)
- Change From Baseline in Whole Brain Atrophy(Baseline, up to Day 720)
- Change From Baseline in Modified Rankin Scale (mRS)(Baseline, up to Day 720)
- Change From Baseline in Visual Acuity on Landolt C Broken Ring Chart (Low Contrast Visual Acuity [LCVA]) and High Contrast Visual Acuity (HCVA)(Baseline, up to Day 720)
- Change from Baseline in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score(Baseline, up to Day 720)
- Change from Baseline in the Revised 15-Component Myasthenia Gravis Quality of Life (MG-QOL15r)(Baseline, up to Day 720)
- Time to Relapse, as Defined by a 1 Point Change in Adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT)(Baseline, up to Day 720)
- Change From Baseline in Inflammatory Neuropathy Cause and Treatment (INCAT) Score(Baseline, up to Day 720)
研究者
研究点 (8)
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