Can a biologic calm the lungs after stem cell transplant?
NCT ID NCT07771855
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether tezepelumab, a biologic drug that blocks a protein called TSLP, can reduce bronchial flare-ups in people who develop bronchiolitis obliterans syndrome (BOS) after an allogeneic stem cell transplant. BOS is a chronic lung condition that causes airway obstruction and breathing difficulties. Participants receive tezepelumab injections every 4 weeks for 12 months. The study compares the number of flare-ups during treatment to the year before, aiming to see if the drug can help manage this challenging condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tezepelumab (an anti-TSLP monoclonal antibody)
- What this could lead to
- If effective, tezepelumab could offer a new treatment to reduce bronchial flare-ups and improve breathing in people with bronchiolitis obliterans syndrome after a stem cell transplant.
- What could go wrong
- This is a small, early-phase trial. The drug may not reduce flare-ups, and side effects are possible. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult recipients, minimum age 18 2. Recipient of an allogeneic bone marrow or haematopoietic stem cell transplant 3. At more than 3 years after the date of the transplantation 4. BOS defined by the occurrence of a new fixed obstructive ventilatory disorder after the allograft (accepted criteria: FEV1/FVC ≤70% and FEV1 \< 75% pred value and decline of more than 10% over less than 2 years OR FEV1/FVC \> 70% and FEV1 \< 75% pred value and decline of FEV1 more than 10% over less than 2 years and Normal TLC \> 80% OR decline of FEV1 more than 10% over less than 2 years and TLC \> 120% and/or RV/TLC \> 40%) 5. Presenting an exacerbation profile: 2 or more moderate to severe bronchial exacerbations in the previous 12 months 6. On optimal inhaled therapy comprising at least one long-acting bronchodilator and one inhaled corticosteroid for at least three months. 7. Stable dose of systemic immunosuppressive regimen for the last 4 weeks 8. Being covered by a national health insurance 9. Signed consent form Exclusion Criteria: 1. Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH 2. FEV1\< 20% theorical value 3. Being deprived of liberty or under guardianship 4. Absence of signed consent 5. Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE 6. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy 7. Respiratory infection in the course of treatement (including acute bacterial and viral infection, long term treatment for fungal or non-tuberculosis mycobacteria) 8. History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy 9. Severe GVHD scleroderma-like manifestations of skin making subcutaneous injections of the investigational treatment impossible or overly difficult 10. Pregnant, breastfeeding or lactating women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHRU de Lille
NOT_YET_RECRUITINGLille, France
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CHU Caen Normandie
NOT_YET_RECRUITINGCaen, France
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CHU de Besançon
NOT_YET_RECRUITINGBesançon, France
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Foch Hospital
RECRUITINGSuresnes, 92150, France
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Hôpital Haut-Lévêque - CHU Bordeaux
NOT_YET_RECRUITINGBordeaux, France
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Hôpital Saint-Louis APHP
NOT_YET_RECRUITINGParis, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug combo reset the immune system to beat relapsed leukemia?
- Could faulty stem cells in the airways drive a rare lung disease? a study aims to find out.
- New study aims to predict hidden hepatitis b danger in transplant patients
- Blood-filtering therapy may slow lung decline in transplant patients
- New drug gecacitinib tested for tough transplant complication
- New drug combo may boost stem cell success in rare bone marrow cancer