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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
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Official title: Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-10-30
Completion Date
2027-01
Last Updated
2026-06-05
Healthy Volunteers
No
Interventions
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)