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Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5 (TEAM MDA5)

1 juni 2026 uppdaterad av: Assistance Publique - Hôpitaux de Paris

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

24

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Läkemedel: Teclistamab(SC)
Dosage and subcutaneous administration of Teclistamab: Day 1: 0.06 mg/kg Day 3: 0.3 mg/kg Day 5: 1.5 mg/kg)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To assess the length of stay in hospital
Tidsram: at 90 days
Total hospital length of stay, from admission to discharge
at 90 days
To evaluate disease severity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Assistance Publique - Hôpitaux de Paris

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 oktober 2026

Primärt slutförande (Beräknad)

1 januari 2027

Avslutad studie (Beräknad)

1 januari 2027

Studieregistreringsdatum

Först inskickad

1 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • APHP251597
  • 2026-526467-38-00 (Ctis)

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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