Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5Phase 2TEAM MDA5NCT07631208
Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5
A Phase 2 study testing Teclistamab(SC) in people with Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5
- What is being tested?
- Teclistamab(SC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Teclistamab(SC)
- Keywords
- severe rapidly progressive interstitial lung disease, anti-MDA5, Teclistamab, transplant-free survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Teclistamab(SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 90 days
Secondary outcomes (6)
To assess the length of stay in hospital
Total hospital length of stay, from admission to discharge
Measured: at 90 days
To evaluate disease severity
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).
Measured: at 90 days
To evaluate the response of Interstitial Lung Disease on imaging
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
Measured: From enrollment to the end at week 24
To assess the tolerance profile of teclistamab
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.
Measured: to day 1 of treatment to the end of treatment (4 week )
To evaluate the response of extra-respiratory manifestations including muscular involvement
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)
Measured: From Day 0 at week 24
To evaluate overall survival
Overall Survial defined as the time from inclusion to death from any cause, with documentation of the causes of death.
Measured: from inclusion to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start30 Oct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631208
- Sponsor's protocol ID
- APHP251597
- Other IDs
- 2026-526467-38-00
- Acronym
- TEAM MDA5
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5.
- ClinicalTrials.gov ID
- NCT07631208
- Acronym / sponsor ID
- TEAM MDA5 / APHP251597
- Keywords
- severe rapidly progressive interstitial lung disease, anti-MDA5, Teclistamab, transplant-free survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Drug
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Experimental |
Primary outcome
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
The primary endpoint is transplant-free survival at 90 days, defined as the time from inclusion to lung transplantation or death from any cause.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab(SC) in people with Severe Rapidly Progressive Interstitial Lung Disease Associated With Anti-MDA5, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yurdagül UZUNHAN, Pr (+33148955280, yurdagul.uzunhan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.