A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis (RECLAIM-LN)
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)
調査の概要
状態
介入・治療
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Fate Clinical Trials
- 電話番号：858-875-1800
- メール：clinicaltrials@fatetherapeutics.com
研究連絡先のバックアップ
- 名前：Natalie Shiff, MD
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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:
- Antinuclear antibody (ANA)
- Anti-double-stranded DNA (anti-dsDNA) or
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
Single Intravenous (IV) infusion of FT819 administered on Day 1
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete Renal Response (CRR) at Week 26
時間枠：Week 26
|
Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria:
|
Week 26
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CRR at Week 52
時間枠：Week 52
|
Proportion of participants who achieve CRR at Week 52
|
Week 52
|
|
CRR at Week 104
時間枠：Week 104
|
Proportion of participants who achieve CRR at Week 104
|
Week 104
|
|
Overall Renal Response
時間枠：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
時間枠：Up to approximately 2 years
|
PRR is defined as achievement of all of the following:
|
Up to approximately 2 years
|
|
Lupus Low Disease Activity State (LLDAS)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FT819-201
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
全身性エリテマトーデスの臨床試験
-
Beijing Immunochina Medical Science & Technology...まだ募集していません体系的なループスerythematosusを治療するのは困難です
FT819の臨床試験
-
Fate Therapeutics募集ループス腎炎 | 全身性エリテマトーデス (SLE) | 全身性硬化症（SSc） | 抗栄養性細胞質抗体（ANCA） - 関連血管炎（AAV） | 特発性炎症性筋炎（IIM）アメリカ, イギリス, フランス, スウェーデン