Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teclistamab(SC).
- Who it may be relevant to
- Registry conditions: Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5.
Overview
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.
Interventions
- Drug 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)
Primary outcome measures
- 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. [Time frame: at 90 days]
Secondary outcome measures (6)
- To assess the length of stay in hospital [Time frame: at 90 days]
- To evaluate disease severity [Time frame: at 90 days]
- To evaluate the response of Interstitial Lung Disease on imaging [Time frame: From enrollment to the end at week 24]
- To assess the tolerance profile of teclistamab [Time frame: to day 1 of treatment to the end of treatment (4 week )]
- To evaluate the response of extra-respiratory manifestations including muscular involvement [Time frame: From Day 0 at week 24]
- To evaluate overall survival [Time frame: from inclusion to day 90]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07631208 · APHP251597 · 2026-526467-38-00