Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progress… (NCT07631208) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5
24 participantsStarted 2026-10-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.