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Safety Study of CD19.CAR T Cells in Patients with Autoimmune‑Associated Severe Interstitial Lung Fibrosis

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with severe scarring of the lungs (known as interstitial lung fibrosis) that occurs together with certain immune‑system diseases, such as Systemic Sclerosis, ANCA-associated Vasculitis, seropositive Rheumatoid Arthritis, Sjögren’s disease or anti‑Synthetase Syndrome, are being studied. The treatment uses a special type of immune cell called CD19.CAR T cells, which are ordinary T‑lymphocytes that have been re‑programmed with a RV-SFG.CD19.CD28.4-1BBzeta retroviral vector—a harmless virus that delivers new genetic instructions to the cells. These modified cells are given to the patient through an intravenous infusion, meaning they are slowly delivered into a vein.

The primary purpose of the study is to determine whether this approach can be safely made and given to patients and tolerated without serious side effects. After the cells are prepared in a laboratory, participants receive a single infusion and are then monitored over several months with routine health checks, breathing tests, and blood work to see how well the treatment is tolerated and whether lung function improves. Simple explanations are provided for any medical terms used, such as describing the modified cells as “engineered immune cells” and the virus used for gene delivery as a “carrier that safely introduces new instructions into the cells.”

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After agreeing to participate, you will complete the required paperwork and undergo initial health checks. these checks create a record of your condition before any treatment is given.

  2. Step 2

    Blood collection for cell processing

    A sample of blood is taken to isolate your t lymphocytes, a type of white blood cell that will be modified for the therapy.

  3. Step 3

    Manufacturing of modified t cells

    In a specialized laboratory, your t cells are transduced with a retroviral vector called rv-sfg.cd19.cd28.4-1bbzeta. this process changes the cells so they can target the disease. manufacturing usually takes several weeks.

  4. Step 4

    Pre‑infusion evaluation

    Once the modified cells are ready, you will have a short medical review to confirm that you are fit for the infusion. this includes routine blood tests and a physical check.

  5. Step 5

    Single infusion of cd19.car t cells

    You will receive one intravenous infusion of the modified cells. the dose is 200,000,000 cells, delivered through a vein over a period of time determined by the medical team.

    The infusion is the only time the therapy is administered.

  6. Step 6

    Immediate post‑infusion monitoring

    For the first 24 to 48 hours after the infusion, you will stay in the clinic for close observation. staff will watch for any signs of reaction, such as fever, low blood pressure, or changes in mental status.

  7. Step 7

    Follow‑up visits

    You will return for scheduled visits to evaluate safety and lung function:

    - visit 3 (approximately 3 weeks after infusion) checks early response and any side effects.

    - visit 11 (approximately 11 weeks after infusion) assesses longer‑term tolerance and lung measurements.

    - visit 15 (approximately 15 weeks after infusion) is the final evaluation of the study period.

  8. Step 8

    Final study assessment

    At the last visit, all data are collected to determine whether the therapy was feasible and tolerated. no further treatment is given after this point.

Who can join the trial?

12 criteria

  • Must have confirmed autoantibody‑positive autoimmune disease that has caused lung scarring (lung fibrosis) and have reduced lung function: forced vital capacity (FVC) less than 70% but more than 40% of normal, and carbon monoxide transfer tests (TLCO/VA or TLCO SB) less than 60% but more than 25% of normal. This includes conditions such as rheumatoid arthritis, systemic sclerosis, ANCA‑associated vasculitis, anti‑synthetase syndrome, Sjögren’s disease, or similar autoimmune disorders.
  • Kidney function must be adequate, shown by a blood test called serum creatinine that is no higher than twice the normal upper limit, or an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m² (a measure of how well the kidneys filter waste).
  • Liver function must be adequate: the enzyme alanine aminotransferase (ALT) must be no more than three times the normal upper limit, and bilirubin (a waste product from red blood cells) must be 2.0 mg/dL or less, unless a known harmless condition (Gilbert–Meulengracht syndrome) is present, in which case slightly higher levels are allowed.
  • Breathing reserve must be sufficient: shortness of breath should be mild (grade 2 or less), oxygen level in the blood while breathing normal air must be over 85%, and forced vital capacity (FVC) must be above 40% of normal.
  • Heart function must be stable, with a left ventricular ejection fraction (LVEF) of at least 40% as measured by an ultrasound of the heart (echocardiogram).
  • If moderate or severe pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) is present, the patient must already be taking at least two approved medicines for this condition.
  • Absolute neutrophil count (ANC) must be 1,000 cells per mm³ or higher (a measure of a type of white blood cell important for fighting infection).
  • Absolute lymphocyte count (ALC) must be 400 cells per mm³ or higher (another type of white blood cell important for immune response).
  • Age must be between 18 and 70 years.
  • Women who could become pregnant and all male participants must agree to use highly effective contraception (birth control) for one year after receiving the cell therapy.
  • Must be able to understand what the trial involves and follow the required procedures.
  • Must sign a written informed consent form before any screening tests are done.

Who cannot join the trial?

13 criteria

  • You must not have taken strong immune‑suppressing medicines such as biological DMARDs within the last 3 months, conventional synthetic DMARDs within the last 6 weeks, or JAK inhibitors within the last month before the blood‑cell collection (called leukapheresis), except for low‑dose prednisolone (30 mg per day or less) and certain bridging medicines that follow special timing rules.
  • You cannot be pregnant or nursing (breast‑feeding).
  • You must not be allergic or intolerant to any of the ingredients (excipients) used in the cell product.
  • You cannot be taking part in another clinical trial when you are screened for this study.
  • You need to be able to understand German well enough to follow the study procedures.
  • You must not have a current hepatitis B or hepatitis C infection (detected by antigen or DNA/RNA tests), which are liver viruses.
  • You must not be HIV‑positive (infection with the human immunodeficiency virus).
  • You cannot have an uncontrolled, life‑threatening bacterial, viral, or fungal infection at the time you join the study.
  • You must not have a severe additional illness such as uncontrolled high blood pressure, serious heart failure (New York Heart Association class III‑IV), or uncontrolled diabetes.
  • You cannot have had unstable chest pain (unstable angina) or a heart attack within the past 3 months.
  • Your kidney function must be adequate; specifically, a glomerular filtration rate (GFR) lower than 30 mL/min/1.73 m² excludes you.
  • You cannot have any current or recent cancer, except for non‑melanoma skin cancer, early‑stage cervical or breast cancer in‑situ, low‑grade prostate cancer (Gleason score 6) treated curatively without recurrence for at least 3 years, or any other cancer that has been completely remission for 5 years or more.
  • If your autoimmune disease is actively affecting the brain or spinal cord (central nervous system involvement), you cannot take part.
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Investigated drugs

CD19 CAR T cells are a type of cell therapy made from a patient’s own immune cells (T lymphocytes). In the laboratory, these cells are changed using a special virus so they can recognize and attach to a protein called CD19, which is found on certain immune cells that may be involved in autoantibody‑positive autoimmune diseases. After the modification, the cells are given back to the patient through an IV infusion. In this trial, the researchers are testing whether giving these engineered T cells is safe and possible for people who have autoimmune diseases with severe scarring of the lungs (interstitial lung fibrosis). The goal is to see if the therapy can help control the autoimmune activity and improve lung health.

What is already known about the treatment

CD19.CAR T cells - The medication is given as an intravenous infusion of a sterile solution that contains a patient’s own T‑lymphocytes that have been genetically changed with a retroviral vector to express a CD19‑CAR with CD28 and 4‑1BB signaling parts. It is an experimental therapy that is currently being tested in early‑phase clinical trials and has not yet received standard medical approval. The treatment is intended for people with autoantibody‑positive autoimmune diseases who have severe, treatment‑resistant interstitial lung fibrosis. The engineered T cells recognize the CD19 marker, become activated through the CD28 and 4‑1BB signals, and then attack the disease‑related cells, classifying this product as a chimeric antigen receptor (CAR) T‑cell therapy, a type of adoptive cell‑based immunotherapy.

Investigated diseases

  • Systemic Sclerosis

    an autoimmune disorder that causes thickening and hardening of the skin and internal organs; in some patients the lungs develop scarring (fibrosis) that becomes worse over time, reducing breathing ability.

  • ANCA‑associated Vasculitis

    a group of autoimmune diseases that cause inflammation of small blood vessels; when the lungs are involved, the inflammation can trigger scar tissue formation that gradually worsens.

  • Rheumatoid Arthritis (seropositive)

    a chronic autoimmune joint disease marked by antibodies against rheumatoid factor; in a subset of patients the inflammation spreads to the lungs, leading to slowly progressive scarring of lung tissue.

  • Sjogren’s disease

    an autoimmune condition that primarily attacks moisture‑producing glands; lung involvement may appear as inflammation that slowly evolves into fibrotic changes, limiting airflow.

  • Anti‑Synthetase Syndrome

    an autoimmune disease characterized by antibodies against amino‑acyl tRNA synthetases and muscle inflammation; lung disease often begins as inflammation and can advance to persistent fibrosis that limits lung function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519592-26-00Protocol codeHD-CAR-ILD-1Estimated enrolment10 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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