Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5 (TEAM MDA5)
Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5.
Patients with severe, rapidly progressive diffuse interstitial lung disease (RP ILD) with anti-MDA5 have an appalling prognosis and the lack of effective medical treatment leads to lung transplantation being proposed as salvage treatment. Currently, transplant-free survival at 90 days (D90) is approximately 25%, dropping to less to 10% among those requiring mechanical ventilation. Peripheral lymphopenia and elevated anti-MDA5 antibody levels are associated with greater disease severity, highlighting the involvement of mature T and B lymphocytes in disease pathogenesis.
Teclistamab, a bispecific antibody targeting the B-cell maturation antigen (BCMA) on plasma cells and engaging T cells - approved for the treatment of refractory multiple myeloma - has recently shown rapid and promising effects in patients with autoimmune conditions, including one MDA5-positive patient, while maintaining a favourable safety profile. We hypothesize that this bispecific antibody could represent a promising and safe therapeutic option for patients with severe MDA5-associated RP-ILD.
調査の概要
状態
介入・治療
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：Yurdagül UZUNHAN, Pr
- 電話番号：+33148955280
- メール：yurdagul.uzunhan@aphp.fr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patient ≥ 18 years old
- MDA5 antibody positivity
- ILD confirmed by chest HRCT
- Within less than 3 months after disease onset
- Refractory after more than 7 days to high dose steroids and two immunosuppressants drugs as first-line treatment.
- Confirmation of refractoriness by the national emergency multidisciplinary discussion (MDD),
- Worsening of respiratory symptoms with respiratory distress defined by increase in oxygen supply to reach SpO2>95% or requirement of mechanical ventilation
- Written informed consent obtained from the patient or the trusted support person designated in advance by the patient
- Patients covered by the French social security system
- Effective contraception for woman of childbearing age during treatment and for five months after the last dose of teclistamab.
- Effective contraception for men, having a partner of childbearing age, during treatment and for three months after the last dose of teclistamab.
Exclusion Criteria:
- Patient with known hypersensitivity to teclistamab, substance active or excipients, including sodium or polysorbate
- Patient or the trusted person designed by the patient not able to give their consent
- Known diagnosis of a serious comorbidity: active cancer, malignant blood disease, ongoing infection, stroke or seizure within 6 months
- Patient who received a live vaccine within 4 weeks prior to study inclusion.
- Patient under judicial protection, deprivation of liberty
- Patient participating in another clinical trial with an investigational medicinal product
- Pregnant or breastfeeding woman
- Patient on AME (state medical aid)
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：Experimental
Dosage and subcutaneous administration of Teclistamab: Day 1: 0.06 mg/kg Day 3: 0.3 mg/kg Day 5: 1.5 mg/kg) |
Dosage and subcutaneous administration of Teclistamab: Day 1: 0.06 mg/kg Day 3: 0.3 mg/kg Day 5: 1.5 mg/kg)
|
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 |
|---|---|---|
|
The primary objective is to demonstrate the efficacy of teclistamab in improving transplant-free survival of patients with anti-Melanoma differentiation-associated protein 5 associated rapidly progressive diffuse interstitial lung disease.
時間枠：at 90 days
|
The primary endpoint is transplant-free survival at 90 days, defined as the time from inclusion to lung transplantation or death from any cause.
|
at 90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To assess the length of stay in hospital
時間枠：at 90 days
|
Total hospital length of stay, from admission to discharge
|
at 90 days
|
|
To evaluate disease severity
時間枠：at 90 days
|
Disease severity evaluated using the World Health Organization Clinical Progression Scale adapted for Interstitial Lung Disease-associated respiratory failure (11-point ordinal scale from 0 to 10).
|
at 90 days
|
|
To evaluate the response of Interstitial Lung Disease on imaging
時間枠：From enrollment to the end at week 24
|
Interstitial Lung Disease response will be based on evolution of Interstitial Lung Disease extent on centralized chest Computed Tomography at Day 0, Week 2, Week 4, Week 12 and Week 24
|
From enrollment to the end at week 24
|
|
To assess the tolerance profile of teclistamab
時間枠：to day 1 of treatment to the end of treatment (4 week )
|
Tolerance assessed by the occurrence and gradation of adverse events, including infections complications detected by microbiological monitoring protocolised in ICU units during the follow-up period.
|
to day 1 of treatment to the end of treatment (4 week )
|
|
To evaluate the response of extra-respiratory manifestations including muscular involvement
時間枠：From Day 0 at week 24
|
Dermatomyositis disease monitoring assessed at Day 0, Week 2, Week 4, Week 12 and Week 24 through: Manual Muscle Testing 8 score (set of 8 designated muscles tested unilaterally)
|
From Day 0 at week 24
|
|
To evaluate overall survival
時間枠：from inclusion to day 90
|
Overall Survial defined as the time from inclusion to death from any cause, with documentation of the causes of death.
|
from inclusion to day 90
|
協力者と研究者
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
キーワード
その他の研究ID番号
- APHP251597
- 2026-526467-38-00 (Ctis)
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
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