A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 32
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 12 to 70 years old.
- •Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
- •Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
- •Health Status: Adequate organ function to tolerate treatment.
- •Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.
排除标准
- •Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
- •Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
- •Active Infections: No recent or ongoing serious infections.
- •Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
- •Allergies: No known allergies to study treatments.
- •Weight Restriction: Must weigh at least 50 kg (110 lbs).
研究组 & 干预措施
Regimen A (Single dose with AMP)
干预措施: Cyclophosphamide (Drug)
Regimen C (Two-dose with AMP)
干预措施: Fludarabine (Drug)
Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)
干预措施: FT819 (Drug)
Regimen C (Two-dose with AMP)
干预措施: Cyclophosphamide (Drug)
Regimen A (Single dose with AMP)
干预措施: Bendamustine (Drug)
Regimen B (Single-dose without AMP, with background therapy)
干预措施: FT819 (Drug)
Regimen C (Two-dose with AMP)
干预措施: FT819 (Drug)
Regimen C (Two-dose with AMP)
干预措施: Bendamustine (Drug)
Regimen A (Single dose with AMP)
干预措施: FT819 (Drug)
Regimen D (Two-dose without AMP, with background therapy)
干预措施: FT819 (Drug)
Regimen A (Single dose with AMP)
干预措施: Fludarabine (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to approximately 2 years
The number of participants with TEAEs will be reported.
Number of participants with serious TEAEs
时间窗: Up to approximately 2 years
The number of participants with serious TEAEs will be reported.
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Up to approximately 29 days
The number of participants with DLTs will be reported.
Recommend Phase 2 dose (RP2D) of FT819
时间窗: Up to approximately 2 years
The RP2D will be determined.
次要结局
- Plasma concentration of FT819(At designated time points up to approximately 29 days)
- Impact of treatment on quality of life(Up to approximately 2 years)
- Disease Activity in Participants with Lupus Nephritis(Up to approximately 2 years)
- Disease Activity(Up to approximately 2 years)