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A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis (RECLAIM-LN)

2026年9月10日 更新者：Fate Therapeutics

A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)

The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a multicenter, phase 2 single-arm trial designed to evaluate the efficacy and safety of FT819 in participants with moderate-to-severe systemic lupus erythematosus (SLE) with Class III/IV lupus nephritis (LN) (with or without concomitant Class V involvement) refractory to at least 2 immunosuppressive therapies prior to trial intervention.

Participants will undergo a screening period of up to 28 days. Following screening, trial intervention will consist of bendamustine administration followed by a single dose of FT819. Efficacy, safety, and exploratory assessments will be conducted at predefined timepoints through Month 24 of post-treatment follow-up (PTFU). Following completion of these scheduled assessments, participants will continue in long-term follow-up (LTFU) for up to 15 years after FT819 administration to monitor ongoing safety and survival.

Efficacy and disease activity will be assessed using standard LN measures, including complete renal response (CRR) and PRR (partial renal response), as well as clinician-reported outcomes, such as the SLEDAI-2K, BILAG, and PGA, performed at specified timepoints.

研究类型

介入性

注册 (估计的)

53

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Natalie Shiff, MD

学习地点

  • 美国
    • California
      • Beverly Hills、California、美国、90210
        • 招聘中
        • Wallace Rheumatic Studies Center
      • Fontana、California、美国、92335
        • 招聘中
        • Kaiser Permanente Fontana
      • Fullerton、California、美国、92835
        • 招聘中
        • Providence Medical Foundation
      • Irvine、California、美国、92868
        • 招聘中
        • University of California Irvine
      • San Francisco、California、美国、64110
        • 招聘中
        • University of California San Francisco
    • Florida
      • Cooper City、Florida、美国、33024
        • 招聘中
        • Gnp Research
      • Gainesville、Florida、美国、32610
        • 招聘中
        • University of Florida Clinical Research Center
      • Miami、Florida、美国、33155
        • 招聘中
        • Nicklaus Children's Hospital
      • Miami、Florida、美国、33133
        • 招聘中
        • Miami Dermatology and Laser Research
    • Nebraska
      • Omaha、Nebraska、美国、68105
        • 招聘中
        • University of Nebraska Medical Center
    • North Carolina
      • Fayetteville、North Carolina、美国、28304
        • 招聘中
        • Cross Creek Medical Clinic
    • Texas
      • Dallas、Texas、美国、75390
        • 招聘中
        • The University of Texas Southwestern Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

INCLUSION CRITERIA:

  • Age ≥12 to ≤70 years
  • Diagnosis of SLE per EULAR/ACR 2019 classification criteria
  • Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification

  • Positivity for at least one of the following autoantibodies at screening:

    1. Antinuclear antibody (ANA)
    2. Anti-double-stranded DNA (anti-dsDNA) or
    3. Anti-Smith antibody

  • Active disease, defined as:

    a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g/g; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible

  • Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN

EXCLUSION CRITERIA:

  • Evidence of inadequate organ function during the screening period
  • Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
  • History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity
  • Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
  • Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant
  • History of malignancy in the prior 5 years
  • Known allergy to the following FT819 components: albumin (human) or DMSO
  • History of intolerance or contraindication to bendamustine
  • Body weight <30 kg
  • Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：FT819
FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CD19-targeted CAR regulated by the TRAC locus, given as a single IV infusion
生物：FT819
Single Intravenous (IV) infusion of FT819 administered on Day 1

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Complete Renal Response (CRR) at Week 26
大体时间：Week 26

Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria:

  • UPCR <0.5 g/g
  • Estimated glomerular filtration rate (eGFR) ≥85% of baseline or ≥60 mL/min/1.73 m2
  • No use of rescue therapy
Week 26

次要结果测量

结果测量
措施说明
大体时间
CRR at Week 52
大体时间：Week 52
Proportion of participants who achieve CRR at Week 52
Week 52
CRR at Week 104
大体时间：Week 104
Proportion of participants who achieve CRR at Week 104
Week 104
Overall Renal Response
大体时间：Up to approximately 2 years
Proportion of participants who achieve an overall renal response, defined as achievement of either CRR or partial renal response (PRR), evaluated at Week 26, Week 52, and Week 104
Up to approximately 2 years
Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104
大体时间：Up to approximately 2 years

PRR is defined as achievement of all of the following:

  • ≥50% reduction in UPCr from baseline and to <3 g/g if baseline UPCr ≥3 g/g
  • eGFR ≥80% of baseline or ≥60 mL/min/1.73 m2
  • No use of rescue therapy
Up to approximately 2 years
Lupus Low Disease Activity State (LLDAS)
大体时间：Up to approximately 2 years
Proportion of participants who achieve lupus low disease activity state (LLDAS) at Week 26, Week 52, and Week 104
Up to approximately 2 years
Definition of Remission in SLE (DORIS)
大体时间：Up to approximately 2 years
Proportion of participants who achieve a definition of remission in SLE (DORIS) at Week 26, Week 52, and Week 104
Up to approximately 2 years
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
大体时间：Up to approximately 2 years
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (adults age ≥18 years) score at Week 26, Week 52, and Week 104
Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4)
大体时间：Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4) at Week 26, Week 52, and Week 104
Up to approximately 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fate Therapeutics

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月27日

初级完成 (估计的)

2029年7月1日

研究完成 (估计的)

2030年1月31日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FT819-201

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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