Experimental cell therapy targets lung scarring in End-Stage disease
NCT ID NCT07329959
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new cell therapy for people with end-stage idiopathic pulmonary fibrosis (IPF), a disease that causes severe lung scarring and breathing failure. The therapy uses specially engineered immune cells to target and reduce scarring in the lungs. The study will enroll 8 adults to check if the treatment is safe and can improve lung function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 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 to 75 years
- 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\. Aged between 18 and 75 years, inclusive, with a diagnosis of idiopathic pulmonary fibrosis (IPF). 2\. Ability to verbally confirm understanding of the risks, benefits, and alternative treatments associated with immunosuppressive CAR-DC therapy. Provision of written informed consent by the patient or their legally authorized representative prior to participation. 3\. Evidence of disease progression (worsening pulmonary fibrosis and declining lung function) despite treatment with standard therapies such as pirfenidone, nintedanib, or other appropriate regimens. 4\. Meets at least one criterion indicating eligibility for lung transplantation due to interstitial lung disease, while not consenting to a transplant. The criteria include: 1. A decline in forced vital capacity (FVC) ≥10% over a 6-month follow-up period. 2. A decline in diffusing capacity of the lungs for carbon monoxide (DLCO) ≥10% of predicted value over 6 months. 3. Six-minute walk test results showing oxygen saturation \<88%, a distance walked \<250 meters, or a decline of \>50 meters in distance over 6 months. 4. Presence of pulmonary hypertension (PH) confirmed by right heart catheterization or transthoracic echocardiography. 5. Hospitalization due to respiratory functional decline, pneumothorax, or acute exacerbation. 5\. No prior cellular immunotherapy within the last 3 months. 6. Hematological parameters meeting the following thresholds: hematocrit \>30%, lymphocyte count \>0.5 × 10⁹/L, and platelet count \>60 × 10⁹/L. Exclusion Criteria: 1. History of acute exacerbation of IPF within 4 weeks prior to screening or during the screening period. 2. Presence of interstitial lung disease (ILD) other than IPF, including but not limited to: other forms of idiopathic interstitial pneumonia; ILD associated with fibrogenic agents, environmental exposures, or drug toxicity; other occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; or ILD related to systemic diseases (e.g., vasculitis, infections such as tuberculosis, connective tissue diseases). Cases with uncertain diagnosis require serological testing and/or multidisciplinary team review for confirmation. 3. Presence of significant active infection. 4. History of malignancy, except for malignancies treated with curative intent and with no recurrence for ≥5 years, resected basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix, or resected colonic polyps. 5. Significant history of infectious diseases. 6. Presence of psychiatric illness or other conditions that would compromise the patient's ability to cooperate with study requirements, comply with treatment, or undergo monitoring. 7. Known hypersensitivity to any component of the immunosuppressive CAR-DC cell product. 8. History of severe renal failure requiring renal dialysis, or serum creatinine level \>2.5 mg/dL. 9. Any contraindication to the investigational product or study procedures. 10. Pregnancy or lactation. 11. History of pulmonary embolism (PE), deep vein thrombosis (DVT), or recurrent thromboembolic events. 12. Uncorrected thrombocytopenia (platelet count \<50,000/μL) or systemic coagulopathy (INR \>2.5 or aPTT \>2.5 times the control value in the absence of anticoagulant therapy), or active bleeding with uncorrectable coagulopathy. 13. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \>5.0 times the upper limit of normal (ULN), or total bilirubin \>3 mg/dL.
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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 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
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Other studies related to the condition(s) this trial covers.
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