Clinical trial • Phase II • Immunology

CC-97540 for Systemic lupus erythematosus | Lupus nephritis

Phase II trial of CC-97540 for Systemic lupus erythematosus | Lupus nephritis. open-label, none/not specified-controlled. 54 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus | Lupus nephritis
Trial Stage
Phase II
Drug Modality
Cell therapy|Small molecule|Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
13-06-2025
First CTIS Authorization Date
06-10-2025

Trial design

open-label, none/not specified-controlled Phase II trial across 28 sites in France, Austria, Spain and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
54

Eligibility

Recruits 54 paediatric patients.

Pregnancy Exclusion
Women who are pregnant, nursing, or planning to become pregnant
Vulnerable Population
isVulnerablePopulationSelected = true. The trial includes minors (participants aged 16–17). Country-specific pediatric assent forms and parental/guardian consent documents are provided (examples in the submission: 'L1_SIS and ICF ASSENT 16-17yrs_FR_Redacted', 'L1_SIS and ICF Pediatric 16-17y_AT_redacted', 'L1_SIS minors 16-17 years_IT_Redacted', 'L1_ES_SIS and ICF Pediatric Assent_Redacted', etc.). Parental/guardian consent and pediatric assent procedures are specified via these ICF/assent documents.

Inclusion criteria

  • {"criterion_text":"- Be at least 16 years old and must have a body weight of ≥ 40 kg"}
  • {"criterion_text":"- Have Systemic Lupus Erythematosus (SLE), as defined by the EULAR/ACR 2019 criteria"}
  • {"criterion_text":"- Have tried glucocorticoids and at least two different immune-suppressing drugs for SLE, for at least three months each, but these treatments didn't work well enough"}
  • {"criterion_text":"- Have active SLE determined by a scoring system called BILAG (a tool to measure SLE disease activity), and by testing for certain proteins in the blood that are signs of SLE"}
  • {"criterion_text":"- Have a specific type of kidney disease related to SLE (lupus nephritis [LN]), they must have had a kidney biopsy within the last six months."}

Exclusion criteria

  • {"criterion_text":"- Other diseases or conditions, or be receiving treatments, that might make it hard to tell if the study drug, CC-97540, is working"}
  • {"criterion_text":"- Uncontrolled infections"}
  • {"criterion_text":"- Serious heart conditions"}
  • {"criterion_text":"- Unresolved problems with their central nervous system"}
  • {"criterion_text":"- Cancer or a disease where the body makes too many lymphocytes, unless they have been free of the disease for at least two years"}
  • {"criterion_text":"- Women who are pregnant, nursing, or planning to become pregnant"}
  • {"criterion_text":"- Having had certain types of cell therapies or a stem cell transplant"}
  • {"criterion_text":"- Having received a live vaccine within six weeks before starting the study drug"}
  • {"criterion_text":"- Poor organ function, as determined by lab tests at the study site"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission","definition_or_measurement_approach":"Proportion of participants achieving drug-free DORIS remission (i.e., meeting the Definition of Remission in Systemic Lupus Erythematosus without medication), as stated in the protocol."}

Secondary endpoints

  • {"endpoint_text":"- Complete renal response (CRR) for participants with baseline lupus nephritis (LN)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Participants with drug-free DORIS remission","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CRR for participants with baseline LN","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Modified CRR for participants with baseline LN","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number and Severity of participants with flares as assessed by SLEDAI flare index","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in proteinuria and estimated glomerular filtration rate (eGFR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC) damage","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number and frequency of participants achieving maintenance of drug-free DORIS remission, LLDAS, and SRI-4.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time from first response to loss of response for drug-free DORIS remission, Time from first response to loss of response for LLDAS, and Time from first response to loss of response for SRI-4","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time from baseline to first drug-free DORIS remission, LLDAS, and SRI-4","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of drug-free status","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of participants achieving DORIS remission regardless of drug-free status","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Cumulative glucocorticoid dose post-infusion used for SLE treatment","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change of serum autoantibodies and complement factors from baseline","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue, SF 36 v2 Acute, EQ-5D-5L, Patient Global Impression of Severity (PGI-S) Pain, and PGI-S Fatigue","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Patient Global Impression of Change (PGI-C) Pain and PGI-C Fatigue","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
54
Recruitment Window Months
82
Consent Approach
Informed consent is obtained using country-specific subject information and informed consent form (SIS/ICF) documents. Pediatric assent and parental/guardian consent are provided for minors (16–17 years) — country-specific pediatric assent documents are included (examples: 'L1_SIS and ICF ASSENT 16-17yrs_FR_Redacted', 'L1_SIS and ICF Pediatric 16-17y_AT_redacted', 'L1_SIS minors 16-17 years_IT_Redacted', 'L1_ES_SIS and ICF Pediatric Assent_Redacted'). ICFs are available in multiple country-specific translations (documents in French, German/AT, Spanish, Italian, Portuguese, Polish, English, Dutch/BE are present in the submission).

Geography

Total Number Of Sites
28
Total Number Of Participants
35

France

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
232
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service hématologie
Principal Investigator Name
Alain LESCOAT
Principal Investigator Email
alain.lescoat@chu-rennes.fr
Contact Person Name
Alain LESCOAT
Contact Person Email
alain.lescoat@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Département de Rhumatologie
Principal Investigator Name
Jacques MOREL
Principal Investigator Email
j-morel@chu-montpellier.fr
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de médecine interne
Principal Investigator Name
Zahir AMOURA
Principal Investigator Email
zahir.amoura@aphp.fr
Contact Person Name
Zahir AMOURA
Contact Person Email
zahir.amoura@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Nephrology and organs transplantation
Principal Investigator Name
Stanislas FAGUER
Principal Investigator Email
faguer.s@chu-toulouse.fr
Contact Person Name
Stanislas FAGUER
Contact Person Email
faguer.s@chu-toulouse.fr

Austria

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
202
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine 3, Division of Rheumatology
Principal Investigator Name
Paul Studenic
Principal Investigator Email
paul.studenic@meduniwien.ac.at
Contact Person Name
Paul Studenic
Contact Person Email
paul.studenic@meduniwien.ac.at
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
IIIrd Medical Department
Principal Investigator Name
Michael Leisch
Principal Investigator Email
m.leisch@salk.at
Contact Person Name
Michael Leisch
Contact Person Email
m.leisch@salk.at

Spain

Earliest CTIS Part Ii Submission Date
18-09-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
203
Number Of Sites
6
Number Of Participants
3

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Rheumatology
Principal Investigator Name
Josefina Cortes-Hernandez
Principal Investigator Email
fina.cortes@vhir.org
Contact Person Name
Josefina Cortes-Hernandez
Contact Person Email
fina.cortes@vhir.org
Site Name
Hospital Universitario Donostia
Department Name
Hematology
Principal Investigator Name
Carlos Panizo Santos
Principal Investigator Email
XXXX@XXXX.XX
Contact Person Name
Carlos Panizo Santos
Contact Person Email
XXXX@XXXX.XX
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Rheumatology
Principal Investigator Name
Carlos Marras Fernandez-Cid
Principal Investigator Email
carlos.marras@carm.es
Contact Person Name
Carlos Marras Fernandez-Cid
Contact Person Email
carlos.marras@carm.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Rheumatology
Principal Investigator Name
Antonio Fernandez Nebro
Principal Investigator Email
XXXX@XXXX.XX
Contact Person Name
Antonio Fernandez Nebro
Contact Person Email
XXXX@XXXX.XX
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Rheumatology
Principal Investigator Name
Jordi Anton
Principal Investigator Email
janton@sjdhospitalbarcelona.org
Contact Person Name
Jordi Anton
Site Name
Hospital Universitario De La Princesa
Department Name
Rheumatology
Principal Investigator Name
Rosario García de Vicuña Pinedo
Principal Investigator Email
XXXX@XXXX.XX
Contact Person Name
Rosario García de Vicuña Pinedo
Contact Person Email
XXXX@XXXX.XX

Italy

Earliest CTIS Part Ii Submission Date
05-09-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
216
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
UOC Rheumatology
Principal Investigator Name
Oscar Massimiliano Epis
Principal Investigator Email
xxx@xxx
Contact Person Name
Oscar Massimiliano Epis
Contact Person Email
xxx@xxx
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Department of Paediatric Haematology and Oncology
Principal Investigator Name
Franco Locatelli
Principal Investigator Email
xxx@xxx
Contact Person Name
Franco Locatelli
Contact Person Email
xxx@xxx
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Rheumatology Unit
Principal Investigator Name
Marta Mosca
Principal Investigator Email
xxx@xxx
Contact Person Name
Marta Mosca
Contact Person Email
xxx@xxx
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Rheumatology
Principal Investigator Name
Maria Antonietta D'Agostino
Principal Investigator Email
xxx@xxx
Contact Person Name
Maria Antonietta D'Agostino
Contact Person Email
xxx@xxx

Germany

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
196
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Rheumatology and Immunology
Principal Investigator Name
Georg Schett
Principal Investigator Email
georg.schett@uk-erlangen.de
Contact Person Name
Georg Schett
Contact Person Email
georg.schett@uk-erlangen.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumazentrum Ruhrgebiet Herne
Principal Investigator Name
Xenofon Baraliakos
Principal Investigator Email
xenofon.baraliakos@elisabethgruppe.de
Contact Person Name
Xenofon Baraliakos
Site Name
Universitaet Leipzig
Department Name
Hematology, Cell Therapy and Hemostaseology
Principal Investigator Name
Vladan Vucinic
Principal Investigator Email
vladan.vucinic@medizin.uni-leipzig.de
Contact Person Name
Vladan Vucinic
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Rheumatology and Clinical Immunology
Principal Investigator Name
David Simon
Principal Investigator Email
david.simon@charite.de
Contact Person Name
David Simon
Contact Person Email
david.simon@charite.de
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Hematology, Oncology
Principal Investigator Name
Dimitrios Mougiakakos
Principal Investigator Email
dimitrios.mougiakakos@med.ovgu.de
Contact Person Name
Dimitrios Mougiakakos
Site Name
University Hospital Cologne AöR
Department Name
Internal Medicine, Clinical Immunology and Rheumatology
Principal Investigator Name
Philipp Koehler
Principal Investigator Email
philipp.koehler@uk-koeln.de
Contact Person Name
Philipp Koehler
Contact Person Email
philipp.koehler@uk-koeln.de

Denmark

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
197
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Rigshospitalet
Department Name
Rheumatology
Principal Investigator Name
Christoffer Tandrup Nielsen
Principal Investigator Email
christoffer.tandrup.nielsen.01@regionh.dk
Contact Person Name
Christoffer Tandrup Nielsen
Site Name
Odense University Hospital
Department Name
Rheumatology
Principal Investigator Name
Anne Voss
Principal Investigator Email
Anne.Voss@rsyd.dk
Contact Person Name
Anne Voss
Contact Person Email
Anne.Voss@rsyd.dk

Belgium

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
211
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
UZ Leuven
Department Name
Rheumatology
Principal Investigator Name
Ellen De Langhe
Principal Investigator Email
ellen.delanghe@uzleuven.be
Contact Person Name
Ellen De Langhe
Contact Person Email
ellen.delanghe@uzleuven.be

Portugal

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
205
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Rheumatology
Principal Investigator Name
Nikita Khmelinskii
Principal Investigator Email
xxxxxxx@gmail.com
Contact Person Name
Nikita Khmelinskii
Contact Person Email
xxxxxxx@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
209
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
Department Name
Oddział Reumatologii I Rehabilitacji
Principal Investigator Name
Aleksandra Zoń-Giebel
Principal Investigator Email
sreumatologia@szpital1.bytom.pl
Contact Person Name
Aleksandra Zoń-Giebel
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Transplantacji Szpiku i Onkohematologii
Principal Investigator Name
Sebastian Giebel
Principal Investigator Email
sebastian.giebel@io.gliwice.pl
Contact Person Name
Sebastian Giebel
Contact Person Email
sebastian.giebel@io.gliwice.pl

Sponsor

Primary sponsor

Full Name
Celgene Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Pharmaceutical Product Development LLC
Responsibilities
PK analysis
Name
Endpoint Clinical Inc.
Responsibilities
IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment (EU only)
Name
WCG Clinical Inc.
Responsibilities
Web-based Site training solution / Investigator Portal
Name
Iqvia Inc.
Responsibilities
Site Payments
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central Lab, Sample mgmt, kit/material supply, Storage and distribution of samples to other vendors
Name
Signant Health Global LLC
Responsibilities
eCOA

Third parties

  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Web-based Site training solution / Investigator Portal","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"Development of Electronic Health Records (HER) systems","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta Biosciences","duties_or_roles":"Cell Therapy support; RNA-ISH Processing","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab, Sample mgmt, kit/material supply, Storage and distribution of samples to other vendors","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment (EU only)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab, Sample mgmt, kit/material supply, Storage and distribution of samples to other vendors","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Subject reimbursement and subject stipend and subject travel arrangements","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Patient Facing Recruitment, Retention support, Site Support, HCP Facing Materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"ProtaGene CGT GmbH","duties_or_roles":"ISA Processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"eCOA licensing services","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage for CA061-1011","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CD19-Targeted NEX-T CAR T
Active Substance
CC-97540
Modality
Cell therapy
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
10 (unit: Other)
Investigational Product Name
FLUDARABINE PHOSPHATE
Active Substance
FLUDARABINE PHOSPHATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
90 (unit: mg/m2 total)
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
900 (unit: mg/m2 total)
Investigational Product Name
TOCILIZUMAB
Active Substance
TOCILIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Maximum Dose
32 (unit: mg/kg total)
Combination Treatment
Yes

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