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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 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)
Legemiddel: 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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To assess the length of stay in hospital
Tidsramme: at 90 days
Total hospital length of stay, from admission to discharge
at 90 days
To evaluate disease severity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assistance Publique - Hôpitaux de Paris

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. oktober 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. januar 2027

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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