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Experimental cell therapy targets lung scarring in End-Stage disease

NCT ID NCT07329959

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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  1. 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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  2. A doctor treating you

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More trials for these conditions

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