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

NCT07631208 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: APHP2515972026-526467-38-00
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5

Keywords

severe rapidly progressive interstitial lung disease; anti-MDA5; Teclistamab; transplant-free survival

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (6)

• To assess the length of stay in hospital

  at 90 days

• To evaluate disease severity

  at 90 days

• To evaluate the response of Interstitial Lung Disease on imaging

  From enrollment to the end at week 24

• To assess the tolerance profile of teclistamab

  to day 1 of treatment to the end of treatment (4 week )

• To evaluate the response of extra-respiratory manifestations including muscular involvement

  From Day 0 at week 24

Study Arms (1)

Experimental

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)

Drug: Teclistamab(SC)

Interventions

Teclistamab(SC) DRUG

Dosage and subcutaneous administration of Teclistamab: Day 1: 0.06 mg/kg Day 3: 0.3 mg/kg Day 5: 1.5 mg/kg)

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Central Study Contacts

Yurdagül UZUNHAN, Pr

CONTACT

+33148955280; yurdagul.uzunhan@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Drug

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05