Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study of CC-97540 (CD19‑Targeted NEX‑T CAR T) versus drug combination in adults with active systemic sclerosis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on adults with active Systemic Sclerosis, a condition that causes the skin and internal organs to become thick and stiff, often accompanied by Interstitial Lung Disease, a lung problem that makes breathing difficult because of scarring. The experimental therapy being tested combines BMS-986353 with CD19-targeted NEX-T CAR T Cells, a type of cell‑based treatment designed to target specific immune cells. Participants may also receive standard medicines that are commonly used for this disease, including nintedanib, fludarabine phosphate, tocilizumab, cyclophosphamide, and rituximab.

The purpose of the study is to compare how well the new cell‑based therapy works against these standard medicines in improving lung function. Participants are randomly assigned to receive either the experimental treatment or the usual care, and both groups are observed over several months to see changes in breathing ability and skin condition.

During the study, lung capacity is measured using Forced Vital Capacity, which records the amount of air a person can blow out after a deep breath. Participants visit the clinic at regular intervals for safety checks, blood tests, and simple examinations of skin thickness. The overall follow‑up period lasts about a year, allowing researchers to track how the disease progresses or improves.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    On the day of joining the study a series of baseline measurements are performed. these include a lung function test that measures forced vital capacity, a skin thickness evaluation using the modified rodnan skin score, blood laboratory tests and other required safety assessments.

  2. Step 2

    Background medication administration

    After baseline tests the patient receives the standard background drugs:

    fludarabine phosphate 30 mg/m2 given intravenously,

    tocilizumab 24 mg/kg given intravenously,

    cyclophosphamide 300 mg/m2 given intravenously,

    rituximab 1000 mg/m2 given intravenously.

    Each medication is administered according to the protocol schedule; the exact timing is recorded by the study staff.

  3. Step 3

    Test product infusion (cd19‑targeted nex‑t car t cells)

    If the patient is assigned to the experimental arm a single infusion of cd19‑targeted nex‑t car t cells is given. the infusion contains a dose of 10 units and is administered intravenously as a one‑time treatment.

  4. Step 4

    Comparator medication administration

    If the patient is assigned to the comparator arm two additional medicines are used:

    nintedanib oral tablets taken daily; the dose may be 200 mg or 300 mg depending on the treating physician’s instruction,

    tocilizumab 162 mg administered subcutaneously according to the schedule defined in the protocol.

  5. Step 5

    Post‑infusion monitoring

    Following the infusion (whether test product or comparator iv drugs) the patient remains under observation in the clinic. vital signs, laboratory values and any adverse symptoms are checked regularly for several days as required by the study protocol.

  6. Step 6

    Ongoing oral and subcutaneous therapy

    Throughout the study period the patient continues the prescribed oral nintedanib tablets each day.

    Subcutaneous tocilizumab injections are given at the intervals specified in the protocol, typically every few weeks.

  7. Step 7

    Regular follow‑up assessments

    The patient attends scheduled clinic visits for repeated lung function tests, skin assessments and safety labs. these visits occur at predefined intervals until the planned study end date in november 2030.

    Data collected at each visit are used to evaluate changes in forced vital capacity, skin thickness, percentage of predicted forced vital capacity, lung diffusion capacity and time to disease progression.

Who can join the trial?

10 criteria

  • Be at least 16 years old.
  • Have systemic sclerosis (SSc) diagnosed according to the ACR/EULAR 2013 criteria (a set of guidelines doctors use to confirm this disease).
  • Test positive for auto‑antibodies (proteins made by the immune system that mistakenly target the body’s own tissues).
  • Show active lung involvement from SSc on a high‑resolution computed tomography (HRCT) scan (a detailed X‑ray picture of the lungs).
  • Have at least one of the following problems caused by active SSc:
    • Swollen or inflamed joints (painful, stiff joints).
    • Muscle inflammation (muscles that are painful or weak because of inflammation).
    • Heart inflammation (the heart tissue is irritated or damaged).
    • New or worsening skin thickening (skin becomes tighter and harder).
    • High levels of inflammation in the blood (blood tests show the body is inflamed).
    • Have already tried at least one SSc medication for a minimum of 6 months that either did not work well enough or caused side effects.

Who cannot join the trial?

5 criteria

  • You cannot join the study if you need supplemental oxygen to breathe or if your lungs work very poorly (very low lung function).
  • You cannot join the study if you have moderate to severe high blood pressure in the lungs, called pulmonary arterial hypertension, and you require two special medicines for it.
  • You cannot join the study if you have serious lung diseases such as chronic obstructive pulmonary disease (COPD) or asthma that need daily steroid pills, or if you have smoked cigarettes or e‑cigarettes in the last three months, or if you are not willing to stop smoking during the study.
  • You cannot join the study if you have serious stomach or gut problems that require you to receive nutrition through a vein, known as total parenteral nutrition.
  • You cannot join the study if you have dead tissue (called gangrene) in a finger or toe.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • BMS-986353

    is an experimental oral medicine being studied to see if it can improve lung function in people with active systemic sclerosis and interstitial lung disease. In the trial it is taken by mouth and its effectiveness is compared with the usual treatments.

  • CD19-Targeted NEX-T CAR T

    is a cell‑based therapy where a patient’s own immune cells are collected, genetically changed in a lab to recognize the CD19 marker on target cells, and then infused back into the patient through an IV. The modified cells are designed to seek out and destroy disease‑related cells.

  • Nintedanib

    is a pill that blocks signals that lead to scarring and inflammation in the lungs. It is part of the standard care for lung disease linked to systemic sclerosis and is taken by mouth.

  • Fludarabine Phosphate

    is a chemotherapy drug given by IV that suppresses the immune system. In this study it is used to create space in the body so the infused CAR T cells can expand and work better.

  • Tocilizumab

    is an antibody medication that blocks the protein IL‑6, which helps reduce inflammation. It can be given as an IV infusion or a subcutaneous injection and is used to manage skin and joint problems in systemic sclerosis.

  • Cyclophosphamide

    is a chemotherapy drug delivered by IV that weakens the immune system. It is often used as part of standard treatment for severe lung involvement in systemic sclerosis.

What is already known about the treatment

  • Nintedanib

    Nintedanib is taken as an oral tablet that patients swallow. It is an approved drug for lung scarring conditions such as idiopathic pulmonary fibrosis and systemic sclerosis‑related interstitial lung disease. It works by blocking several enzymes that promote the growth of scar tissue in the lungs. Pharmacologically it is classified as a tyrosine‑kinase inhibitor with anti‑fibrotic activity.

  • Fludarabine phosphate

    Fludarabine phosphate is given by intravenous infusion into a vein. It is an approved chemotherapy medicine for certain blood cancers, especially chronic lymphocytic leukemia. The drug interferes with the building blocks of DNA, stopping cancer cells from multiplying. It belongs to the class of purine‑analog antimetabolites.

  • Tocilizumab

    Tocilizumab can be administered either as an intravenous infusion or as a subcutaneous injection under the skin. It is an approved treatment for rheumatoid arthritis and is also used for lung disease in systemic sclerosis. The medicine blocks the interleukin‑6 (IL‑6) receptor, reducing inflammation caused by this signaling molecule. It is classified as an IL‑6 receptor antagonist, a type of biologic therapy.

  • Cyclophosphamide

    Cyclophosphamide is delivered by intravenous infusion into a vein. It is an approved chemotherapy agent for many cancers and is also used in severe autoimmune diseases such as systemic sclerosis. The drug attaches to DNA strands, preventing cells from dividing and leading to the death of harmful immune cells. It is classified as an alkylating agent.

  • CD19‑Targeted NEX‑T CAR T

    CD19‑Targeted NEX‑T CAR T (cc‑97540) is a cell suspension that is infused intravenously, delivering genetically engineered T cells. It is currently an investigational therapy being studied in clinical trials for systemic sclerosis. The engineered T cells are designed to recognize the CD19 protein on certain immune cells and modify the immune response to reduce disease activity. This product belongs to the class of CAR T‑cell therapies, a type of cellular immunotherapy.

  • Rituximab

    Rituximab is given as an intravenous infusion into a vein. It is an approved monoclonal antibody used for B‑cell cancers and several autoimmune disorders, including systemic sclerosis. The drug binds to the CD20 marker on B cells, leading to their removal from the blood and reducing harmful immune activity. It is classified as an anti‑CD20 monoclonal antibody.

Investigated diseases

  • Systemic sclerosis

    It is a chronic autoimmune disease that makes the skin become thick and tight. It often begins with swelling of the fingers and hands. Over time the tightening can spread to the arms, face, and other parts of the body. The disease can also affect blood vessels and internal organs such as the lungs, heart, and kidneys. When organs are involved, symptoms may include shortness of breath and reduced organ function.

  • Interstitial lung disease

    This term refers to a group of conditions that cause scarring of the lung tissue. It usually starts with inflammation that makes the lung tissue stiff. As the scarring progresses, breathing becomes more difficult, especially during activity. A dry cough is a common early sign. Over time the amount of air the lungs can hold may decrease.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524337-11-00Protocol codeCA0611005Estimated enrolment92 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.