NCT07427628尚未招募1 期
A Proof-of-Concept Trial to EvaluAte the EfficaCy and Safety Of Cell Therapy TRX103 Administered Intravenously in Patients With Active, Non-infectious Intermediate, Posterior, and Pan-Uveitis - PEACOCX Study
Quan Dong Nguyen1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of Treatment emergent Adverse events and Serious Adverse events at week 52
研究概览
简要总结
The purpose of this Phase 1, first in uveitis open-label study is to assess the safety and tolerability of TRX-103 in patients with non infectious uveitis (NIU). It is anticipated that up to 18 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 to ≤ 70 years of age at time of consent.
- •Weight of ≥ 40 kg at time of consent.
- •Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
- •Diagnosis of active non-infectious uveitis (NIU); intermediate, posterior, or panuveitis at screening as defined as having at least ONE of the following findings:
- •.≥ 2+ VH (NEI/SUN Scale) OR
- •Active inflammatory chorioretinal or inflammatory retinal lesion or lesions as defined by fluorescein angiography (FA) or optical coherence tomography (OCT).
- •Subjects on treatment with corticosteroids may be included if they meet the following:
- •Prednisone ≤ 20 mg/day; or an equivalent dose of another corticosteroid
- •Have been on a stable dose for at least 7 days prior to TRX103 dose.
- •No ongoing treatment with a systemic non-corticosteroid, biologic, small molecules or immunomodulatory agent.
- •If the patient is on specific therapies such as systemic non-corticosteroid biologic agents, immunomodulatory agents or small molecules etc., appropriate washout periods defined in the protocol must be met prior to infusion at Day 0.
排除标准
- •Any condition preventing evaluation/assessment of both eyes.
- •Any significant ocular disease that could compromise vision.
- •Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to non-uveitis causes.
- •Isolated anterior uveitis.
- •Macular edema as the only sign of uveitis, defined on OCT without active anterior/posterior inflammatory signs.
- •Age-related macular degeneration or serpiginous choroidopathy.
- •Myopic degeneration with active sub-foveal choroidal neovascularization.
- •Confirmed or suspected current infectious uveitis.
- •Has ocular masquerade syndrome, like ocular lymphoma.
- •Any of the following ongoing treatments or anticipated use of any of the following treatments prior to TRX103 dose, for the time periods specified below:
- •Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
- •Small molecules, e.g., JAK inhibitors or TYK2 inhibitors within 4 weeks
- •Anti-vascular endothelial growth factor (anti-VEGF) therapy within 8 weeks
- •TNF inhibitor therapy within 8 weeks
- •Agents that modulate T cells within 3 months
- •IL-6 inhibitors within 8 weeks
- •Therapeutic agents targeted to IL-17 within 4 months
- •Agents that modulate B cells within 6 months
- •Therapeutic agents targeted to IL-12 or IL-23 within 6 months
- •Has received intraocular or periocular (including subtenon, intracanalicular) corticosteroids within 8 weeks prior to TRX103 dose, unless otherwise specified below:
- •Retisert® or Yutiq® (glucocorticosteroid implants) within 3 years prior or has had complications related to the implant;
- •Retisert® (glucocorticosteroid implant) removed within 3 months prior or has had complications related to device removal;
- •Ozurdex® (dexamethasone implant) or Xipere™ (suprachoroidal triamcinolone) within 4 months prior.
- •Ocular surgery within 90 days prior to TRX103 dose in the study eye, including glaucoma surgery (trabeculectomy or aqueous shunt device), and vitreoretinal surgery. Nd: YAG capsulotomy within 30 days prior to TRX103 dose in the study eye is also an exclusion criterion.
- •Any of the following cardiovascular risk factors:
- •History of NYHA Class III or IV criteria cardiac insufficiency
- •Clinically significant cardiac dysrhythmia
- •QTcF > 450 msec (male) or > 470 msec for (female)
- •Unstable angina in last 3 months;
- •Myocardial infarction within past year
- •CABG surgery past year.
- •Impaired kidney function, defined as any of the following:
- •Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula or as measured by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) equation < 40 mL/min/1.73 m2
- •Proteinuria, defined as urine protein/creatinine ratio > 25
- •Symptomatic nephrolithiasis within 6 months of screening.
- •Subjects who are breastfeeding, pregnant, or planning to become pregnant, or subjects of childbearing potential who are unwilling to apply a highly effective birth control method prior to TRX103 dose.
- •Anaphylaxis to fluorescein or unwillingness to undergo fluorescein angiograms.
- •Live vaccine within 6 weeks prior to Day 0 (day of infusion) or expected to need a live vaccine during the study.
- •Active bacterial, viral, fungal, mycobacterial, or other infections that would require treatment. Active infections must be resolved prior to enrollment.
- •Have required management of infections as follows:
- •Currently on suppressive therapy for any chronic infection
- •Hospitalization for infection within past 60 days
- •Use of IV or IM antibacterials, antivirals, antifungals, or anti- parasitic agents within past 60 days
- •History of disseminated herpes zoster, history of or invasive HSV, or recurrent (≥ 2 episodes within last 5 years) localized herpes zoster
- •Infection with Mycobacterium tuberculosis (TB).
- •Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
- •Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).
- •Positive serology for HIV.
- •Lab test results indicating active syphilis infection.
- •History of significant trauma or major surgery within 4 weeks prior to TRX103 dose or scheduled to undergo major surgery during the study.
- 另有 16 项未显示
研究组 & 干预措施
TRX-103 Inpatient
Experimental
Infusion of TRX103 followed by 8 hour in patient observation period
干预措施: TRX103 (Biological)
TRX-103 Outpatient
Experimental
Outpatient Infusion of TRX103 followed by outpatient observation period
干预措施: TRX103 (Biological)
结局指标
主要结局
Incidence of Treatment emergent Adverse events and Serious Adverse events at week 52
时间窗: Up to a year
Detailed physical and eye exams, labs and imaging to be performed at study visits for documenting safety and AE's graded using CTCAE V6.0
Incidence of infections, either bacterial, fungal or viral at week 52
时间窗: Upto 1 year
Negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months.
时间窗: At 3-month, 6-month, and 1-year.
Participants will be tested via pre-defined blood draw for Replication Competent Lentivirus as per FDA guidance for Testing of Retroviral Vector-Based Human Gene Therapy Products
次要结局
- Change in Best-Corrected Visual acuity (BCVA) at week 52, compared to Baseline(Up to a year)
- Change in Central subfield thickness on OCT at week 52 from baseline(Upto a year)
- Change in quality of life at week 52 using NEI VFQ 25 compared to Baseline(Upto a year)
研究者
Quan Dong Nguyen
Professor of Ophthalmology
Stanford University
研究点 (1)
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