Study of BMS-986353, CD19-CAR T Cells, versus SoC in Participants with Active SSc (Breakfree-SSc)

Status Authorised, recruitment pending · 4 EU/EEA countries · 20 sites · Protocol CA0611005

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruitment pending

Participants planned 88

Countries 4

Sites 20

Systemic Sclerosis

The main goal of this study is to test how well BMS-986353 can help patients with active Systemic Sclerosis (SSc) and Interstitial Lung Disease (ILD) to improve the functioning of their lungs, compared to the standard treatments.

Key facts

Sponsor: Celgene Corp.
Participant type: Pediatric, Patients
Age range: 0-17 years, 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Decision date (initial): 2026-06-22
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Celgene Corporation

External identifiers

EU CT number: 2025-524337-11-00
WHO UTN: U1111-1330-3381
ClinicalTrials.gov: NCT07335562

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacodynamic, Pharmacokinetic

Secondary objectives 3

To asses if BMS-986353 works better than standard of care with skin thickening (a common symptom in SSc).
To assess whether BMS-986353, compared to standard of care, helps with improving characteristics in special lung imaging called high-resolution computed tomography scans and other ways of measuring lung function.
To assess whether BMS-986353, compared to standard of care, helps with preventing the disease from getting worse.

Conditions and MedDRA coding

Systemic Sclerosis

Version	Level	Code	Term	System organ class
21.0	LLT	10042953	Systemic sclerosis	10028395
20.0	PT	10042954	Systemic sclerosis pulmonary	100000004855
21.0	LLT	10025109	Lung involvement in systemic sclerosis	10038738

Regulatory references

Scientific advice from competent authorities: Food And Drug Administration, European Medicines Agency
Plan to share IPD: Yes
IPD plan description: BMS will provide access to individual anonymised participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Be at least 16 years old
Have systemic sclerosis (SSc), as defined by the ACR / EULAR 2013 criteria
Have positive auto-antibodies
Have signs of activity in their lungs from SSc, seen on a scan called high-resolution computed tomography (HRCT)
Have at least one of these manifestations caused by active SSc: Swollen or inflamed joints, Muscle inflammation, Heart inflammation, New or worse skin thickening, High levels of inflammation in the blood
Have tried at least one SSc treatment for 6 months, which did not work well enough or caused side effects

Exclusion criteria 5

Need oxygen to breathe or have very poor lung function
Moderate to severe high blood pressure in the lungs (pulmonary arterial hypertension) requiring two special treatments
Serious lung problems, like chronic obstructive pulmonary disease (COPD) or asthma requiring daily steroid pills; smoking cigarettes or e-cigarettes in the last 3 months, or not willing to stop smoking during the study
Serious stomach or gut problems requiring feeding through a vein (total parenteral nutrition)
Gangrene (dead tissue) in a finger or toe

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

How much the amount of air a person can blow out of their lungs (called Forced Vital Capacity, or FVC) changes. This is measured in milliliters (mL).

Secondary endpoints 5

How much the skin thickness (measured by the Modified Rodnan Skin Score, or mRSS) changes.
Changes in lung function (FVC in mL) or in skin thickness (mRSS).
Changes in the percentage of predicted FVC (ppFVC), which compares a person’s lung function to what is expected for someone their age and size.
Changes in how well the lungs transfer oxygen (called DLCO).
How long it takes for the disease to get worse, starting from when a person joins the study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

CD19-Targeted NEX-T CAR T

PRD10435579 · Product

Active substance: CC-97540
Pharmaceutical form: CELL SUSPENSION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 10 Other
Max total dose: 10 Other
Max treatment duration: 5 Week(s)
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

Comparator 4

Rituximab

SUB12570MIG · Substance

Active substance: Rituximab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1000 mg/m2 milligram(s)/square meter
Max total dose: 20000 mg/m2 milligram(s)/square meter
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be over-labeled and repackaged

Nintedanib

SUB120728 · Substance

Active substance: Nintedanib
Pharmaceutical form: CAPSULE, SOFT
Route of administration: ORAL USE
Max daily dose: 300 mg milligram(s)
Max total dose: 328500 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be over-labeled and repackaged

Nintedanib

SUB120728 · Substance

Active substance: Nintedanib
Pharmaceutical form: CAPSULE, SOFT
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 219000 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be over-labeled and repackaged

Tocilizumab

SUB20313 · Substance

Active substance: Tocilizumab
Pharmaceutical form: SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration: SUBCUTANEOUS USE
Max daily dose: 162 mg milligram(s)
Max total dose: 23328 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be over-labeled and repackaged

Auxiliary 3

Fludarabine Phosphate

SUB13897MIG · Substance

Active substance: Fludarabine Phosphate
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 30 mg/m2 milligram(s)/square meter
Max total dose: 90 mg/m2 milligram(s)/square meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be over-labelled and repackaged

Tocilizumab

SUB20313 · Substance

Active substance: Tocilizumab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 24 mg/kg milligram(s)/kilogram
Max total dose: 32 mg/kg milligram(s)/kilogram
Max treatment duration: 31 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be over-labeled and repackaged

Cyclophosphamide

SUB06859MIG · Substance

Active substance: Cyclophosphamide
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 300 mg/m2 milligram(s)/square meter
Max total dose: 900 mg/m2 milligram(s)/square meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be over-labeled and repackaged

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene Corp.

Sponsor organisation: Celgene Corp.
Address: Route 206 And Province Line Road
City: Princeton
Postcode: 08543-4000
Country: United States

Scientific contact point

Organisation: Celgene Corp.
Contact name: GSM-CT

Public contact point

Organisation: Celgene Corp.
Contact name: GSM-CT

Third parties 4

Organisation	City, country	Duties
Labcorp Central Laboratory Services LP ORG-100032236	Indianapolis, United States	Other
Voiant LLC ORG-100051555	Waltham, United States	Other
Signant Health Global LLC ORG-100040604	Blue Bell, United States	Other
Mural Health Technologies Inc. ORG-100051510	Berwyn, United States	Other

Locations

4 EU/EEA countries · 20 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	5	6
Germany	Authorised, recruitment pending	16	6
Italy	Authorised, recruitment pending	6	4
Spain	Authorised, recruitment pending	6	4
Rest of world Japan, Canada, United States, United Kingdom, Switzerland	—	55	—

Investigational sites

France

6 sites · Authorised, recruitment pending

Pellegrin Hospital

Rheumatology, Place Amelie Raba Leon, 33000, Bordeaux

Centre Hospitalier Universitaire De Rennes

Internal Medecine and Clinical Immunology, 2 Rue Henri Le Guilloux, 35000, Rennes

Hospices Civils De Lyon

Pediatric rheumatology, 59 Boulevard Pinel, 69500, Bron

Centre Hospitalier Universitaire De Toulouse

Internal Medecine and Clinical Immunology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9

Les Hopitaux Universitaires De Strasbourg

Rheumatology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2

Assistance Publique Hopitaux De Paris

Rheumatology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris

Germany

6 sites · Authorised, recruitment pending

Universitaetsklinikum Erlangen AöR

Medizinische Klinik 3 - Rheumatologie und Immunologie, Ulmenweg 18, Innenstadt, Erlangen

LMU Klinikum Muenchen AöR

Medizinische Klinik und Poliklinik IV - Sektion Rheumatologie und Klinische Immunologie, Marchioninistrasse 15, Hadern, Munich

Universitaet Leipzig

Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig

Charite Universitaetsmedizin Berlin KöR

Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie - Neue Therapien&Studien, Chariteplatz 1, Mitte, Berlin

Universitaetsklinikum Wuerzburg AöR

Medizinische Klinik und Poliklinik II - Rheumatologie / Klinische Immunologie, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg

Universitaetsklinikum Koeln AöR

Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne

Italy

4 sites · Authorised, recruitment pending

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rheumatology Unit, Largo Francesco Vito 1, 00168, Rome

Ospedale San Raffaele S.r.l.

UOC Rheumatology, Via Olgettina 60, 20132, Milan

Azienda Ospedaliero Universitaria Pisana

UOC Rheumatology, Via Roma 67, 56126, Pisa

ASST Grande Ospedale Metropolitano Niguarda

UOC Rheumatology, Piazza Dell'ospedale Maggiore 3, 20162, Milan

Spain

4 sites · Authorised, recruitment pending

Complexo Hospitalario Universitario A Coruna

Reumatologia, Lugar Jubias De Arriba 84, 15006, A Coruna

Bellvitge University Hospital

Reumatologia, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat

Hospital De La Santa Creu I Sant Pau

Reumatologia, Carrer De San Quinti 89, 08041, Barcelona

Hospital Universitario Regional De Malaga

Reumatologia, Avenida De Carlos De Haya S/N, 29010, Malaga

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 51 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol_2025-524337-11-00_Redacted	PA01 EU
Protocol (for publication)	D4_Statement on validated questionnaires under licence_BE	N/A
Protocol (for publication)	D4_Statement on validated questionnaires under licence_FR	1
Protocol (for publication)	D4_Statement on validated questionnaires under license_DE_ger	NA
Protocol (for publication)	D4_Statement on validated questionnaires under license_ES	1
Protocol (for publication)	D4_Statement on validated questionnaires under license_IT	NA
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_DE	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_FR	1
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_IT	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF FOR PROCESSING PERSONAL DATA_IT_Redacted	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF Main_IT_Redacted	2
Subject information and informed consent form (for publication)	L1_IT_SIS and ICF_Digital Biomarker_Redacted	1
Subject information and informed consent form (for publication)	L1_IT_SIS and ICF_exception-release_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF Exception release_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_FR_Redacted	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_Redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF Newborn	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Newborn__IT	2
Subject information and informed consent form (for publication)	L1_SIS and ICF Newborn_FR_Redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Non-conforming Product_FR_Redacted	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional Future Research_IT_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional Future Research_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional Photography_FR	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pediatric assent_FR_Redacted	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pediatric Assent_Redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF Photography	2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner_ES	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant partner_FR	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Exception release_DE_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Future Research_DE_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Infant follow up_FR	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Infant follow up_FR_TC	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_DE_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Newborn_DE_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Photography_DE_clean	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Photography_IT	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_DE_clean	1
Subject information and informed consent form (for publication)	L1_SIS IC Pregnant participant_IT	1
Subject information and informed consent form (for publication)	L1_SIS IC_Reimbursement_IT_Redacted	1
Subject information and informed consent form (for publication)	L1-SIS IC Pregnant partner_IT	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Nintedanib_RSI and QUALITY	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Rituximab_RSI and QUALITY	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Tocilizumab_RSI and QUALITY	N/A
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-524337-11_DUT-BE_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-524337-11_ES_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-524337-11_FR_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-524337-11_FRE-BE_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-524337-11_GER-BE_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-524337-11_IT_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_EN_2025-524337-11-00_Redacted	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-02-20	Germany	Acceptable with conditions 2026-06-15	2026-06-19