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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Pellegrin Hospital	Bordeaux	France
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Hgvikvcb Utmtxmjsezekg dz A Chjdgu	A Coruna Galicia	Spain
Unzkmlsdlo Hinvnacv Cxiagqk	Cologne	Germany
Koxoorxr day Ukxdwszjwqkp Mmfblhub Ace	Munich	Germany
Umatgsitssxwuusipjccb Wytfjhepv Aum	Wuerzburg	Germany
Hbrkdyiy Dv Lh Snrre Cmjo I Sbuz Phe	Barcelona	Spain
Huwgzdkq Urjxdjguyahgdt Sctmnugirz &lhyqjv Hfhzcmp dl Hrapvvwlouc	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	20.06.2026
Germany	Not yet recruiting	20.06.2026
Italy	Not yet recruiting	20.06.2026
Spain	Not yet recruiting	20.06.2026

Trial locations

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.

Rituximab is an antibody given by IV that targets a protein on certain immune cells, helping to lower abnormal immune activity that contributes to systemic sclerosis.

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 ID:

2025-524337-11-00

Protocol code:

CA0611005

NCT ID:

NCT07335562

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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